Data / Medical devices / United States / Stryker Medical
Stryker Medical: FDA-registered device maker in Portage, MI, United States, 6 510(k) clearances
Stryker Medical is registered with the FDA (registration 1831750) in Portage, MI, United States. It lists 27 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 24, 2023. 66 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1831750
- Address
- 3800 E. Centre Ave., Portage, MI, United States, 49002
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 29, 1977
- Registered through
- 2027
- Brand names listed
- "Gynnie" ObGyn Stretcher, AIR+ Pump, Arm board (Accessory), CHG CPR Board, CHG Prevention Surface Cover, CUB, ComfortGel, ComfortGel SE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bariatric Bed | OSI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bassinet, Hospital | NZG | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bed, Flotation Therapy, Powered | IOQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bed, Manual | FNJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bed, Patient Rotation, Powered | IKZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bed, Pediatric Open Hospital | FMS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Board, Cardiopulmonary | FOA | 1 | Complaint file establishment | accessdata.fda.gov |
| Chair And Table, Medical | KMN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Chair, Examination And Treatment | FRK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Chair, Positioning, Electric | INO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Specification developer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stool, Operating-Room | FZM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stretcher, Hand-Carried | FPP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stretcher, Wheeled | FPO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stretcher, Wheeled, Powered | INK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Table, Obstetrical, Ac-Powered (And Accessories) | HDD | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Transport, Patient, Powered | ILK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 24, 2023 | K222818 | Xpedition Powered Stair Chair (625700000000) | ILK | Substantially Equivalent | Stryker Medical | accessdata.fda.gov |
| May 20, 2014 | K140095 | PRIME ZOOM STRETCHER | INK | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| July 11, 2013 | K130339 | CLINICAL ALERT NOTIFICATION | MSX | Substantially Equivalent | Extension , Inc. | accessdata.fda.gov |
| December 20, 2011 | K113598 | POWER-LOAD COT FASTENER SYSTEM | FPO | Substantially Equivalent | Stryker Medical | accessdata.fda.gov |
| December 16, 2010 | K103536 | IBED WIRELESS WITH IBED AWARENESS | FNL | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| October 16, 1995 | K950889 | ADEL 5000 | HDD | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 18, 2026 | 98426 | Class II | Ongoing | Cub Pediatric Crib, Model FL19H | Cribs sold in the USA are missing two access door warning labels. | accessdata.fda.gov |
| October 31, 2025 | 97953 | Class II | Ongoing | Stryker MV3 bariatric bed, Part Number 5900000001 | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by S | accessdata.fda.gov |
| August 30, 2023 | 93317 | Class II | Ongoing | ProCuity bed series, model number 3009, item number: 300900000000 | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. | accessdata.fda.gov |
| May 24, 2023 | 92499 | Class II | Ongoing | Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Numbe | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion. | accessdata.fda.gov |
| February 1, 2023 | 91716 | Class II | Ongoing | Power-PRO 2. Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001 | Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport. | accessdata.fda.gov |
| November 11, 2022 | 91160 | Class II | Ongoing | Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International) | Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected. | accessdata.fda.gov |
| May 12, 2021 | 88199 | Class II | Ongoing | Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000 | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals | accessdata.fda.gov |
| August 12, 2020 | 86323 | Class II | Terminated | Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100 | Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR | accessdata.fda.gov |
| April 7, 2020 | 85549 | Class II | Terminated | Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory hu | Ambulance Cots may not meet crash test standard BS EN 1789 | accessdata.fda.gov |
| November 20, 2018 | 81610 | Class II | Terminated | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. | accessdata.fda.gov |
| October 10, 2018 | 81393 | Class II | Terminated | Naera Hospital Bassinet, Model No. 4402 | It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highe | accessdata.fda.gov |
| October 8, 2018 | 81211 | Class II | Terminated | The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option | The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment. | accessdata.fda.gov |
| September 6, 2018 | 81103 | Class II | Terminated | Altrix Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the applic | Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan a | accessdata.fda.gov |
| August 13, 2018 | 80894 | Class II | Terminated | IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tis | Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. | accessdata.fda.gov |
| March 12, 2018 | 79630 | Class II | Terminated | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transpo | The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. | accessdata.fda.gov |
| March 9, 2018 | 79817 | Class II | Terminated | 6376 M-1 Cot Fastener, catalog no. 6376000000 | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. | accessdata.fda.gov |
| November 7, 2017 | 79302 | Class III | Terminated | T/Pump temperature therapy pump, Models TP700 and TP700C | The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement. | accessdata.fda.gov |
| July 21, 2017 | 78886 | Class II | Terminated | MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM | It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down). | accessdata.fda.gov |
| March 29, 2017 | 77014 | Class II | Terminated | Medi-Therm Hyper/Hypothermia System, MTA7900 | The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode. | accessdata.fda.gov |
| November 8, 2016 | 75820 | Class II | Terminated | Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled | Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers. | accessdata.fda.gov |
| May 5, 2016 | 74207 | Class II | Terminated | Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environme | Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. In addition to the alleged smoking, one of the reports had also noted that when the user attempted to lower the cot (prior to the alleged smoking) the device went into high speed | accessdata.fda.gov |
| February 5, 2016 | 73403 | Class II | Terminated | Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher | The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jac | accessdata.fda.gov |
| February 2, 2016 | 73255 | Class II | Terminated | S3 MedSurg Bed, Model 3005. Stryker Medical | CPU board failures cause fowler (backrest) electronic controls to stop working. | accessdata.fda.gov |
| December 3, 2015 | 72935 | Class II | Terminated | Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multip | Potential for power cord to melt; hazards include electric shock and fire. | accessdata.fda.gov |
| October 13, 2015 | 72466 | Class II | Terminated | Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or oth | It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/ba | accessdata.fda.gov |
| July 2, 2015 | 73131 | Class II | Terminated | Spirit One A-C Powered Hospital Bed | Inaccurate scale systems | accessdata.fda.gov |
| July 2, 2015 | 71667 | Class II | Terminated | Spirit One A-C Powered Hospital Bed | Customer complaints associated with faulty brake system | accessdata.fda.gov |
| June 4, 2014 | 68470 | Class II | Terminated | InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156. | Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit | accessdata.fda.gov |
| December 27, 2013 | 66861 | Class II | Terminated | The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanke | Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of | accessdata.fda.gov |
| November 26, 2013 | 66468 | Class II | Terminated | Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropri | Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header. | accessdata.fda.gov |
| October 23, 2013 | 66137 | Class II | Terminated | Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surfa | It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed. | accessdata.fda.gov |
| August 19, 2013 | 65922 | Class II | Terminated | The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the he | The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged. | accessdata.fda.gov |
| July 12, 2013 | 65337 | Class II | Terminated | IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes. | Complaints were received from the field indicating that some Air Pumps were flashing and alarming when connected to the IsoGel AIR" surface upon turning the pump on and the setting it to the IsoGel AIR Mode. Upon further investigation, it was determined that the flashing/alarm being experienced was due to the air pressure being out of the expected range; ind | accessdata.fda.gov |
| December 18, 2012 | 63602 | Class II | Terminated | Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op | Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2012. The affected beds may have been built with brake rings that do not meet specifications, negatively impacting the holding force of the brakes. | accessdata.fda.gov |
| October 11, 2012 | 63604 | Class II | Terminated | The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance. | Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted. | accessdata.fda.gov |
| June 27, 2012 | 61671 | Class II | Terminated | Powered Mobility Offers Versatility (MV)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key f | Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient transport devices, merged with an affiliate of Stryker Corporation in August 2009. As part of the due diligence process, Paramed's powered Mobility Offers Versatility (MV) chair was reviewed to identify potential compliance issues in relation to product documentat | accessdata.fda.gov |
| May 17, 2012 | 61712 | Class II | Terminated | GoBed+. Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or care | An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, GoBed II, Rose, and MA204 model beds. Investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. The scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to | accessdata.fda.gov |
| March 12, 2012 | 61054 | Not yet classified | Terminated | Stryker Epic Critical Care Bed (Model 2030), Stryker, Portage, MI 49002 Product Usage: EPIC II (model 2030) Critical Care beds Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of bui | Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, ei | accessdata.fda.gov |
| October 31, 2011 | 60422 | Not yet classified | Terminated | Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional, Stryker Medical, Portage, MI 49002. Intended to provide the patient grea | The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use. | accessdata.fda.gov |
| July 19, 2011 | 59214 | Not yet classified | Terminated | Stryker Medical Stretcher Model 747 Transport A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports f | Stryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used within the Prime Brake Pad Assembly may wear prematurely, over the life of the product. Reduced braking force may result in a patient fall or caregiver muscle strain, either of whi | accessdata.fda.gov |
| July 19, 2011 | 59201 | Not yet classified | Terminated | Sechrist Stryker Medical Stretchers Model 742 Intended to transport patients in a horizontal position. | The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain | accessdata.fda.gov |
| June 28, 2011 | 59112 | Not yet classified | Terminated | Stryker Evacuation Chair Model 6254 It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation. | Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. The rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. The red release bars may bend to the degree that they permanent | accessdata.fda.gov |
| April 29, 2011 | 58487 | Not yet classified | Terminated | Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker fram | Affected mattresses may not conform to federal flammability standards. | accessdata.fda.gov |
| May 15, 2010 | 56628 | Not yet classified | Terminated | Stryker M1 Ambulance cot, Model 6100, Stryker Medical, Kalamazoo, MI. | The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures. | accessdata.fda.gov |
| May 14, 2010 | 56507 | Not yet classified | Terminated | Stryker Epic II Critical Care Bed, Model 2030/2031, Stryker Medical, Kalamazoo, MI. Critical Care Patient Bed. | The Fowler mechanism may malfunction, preventing it from being lowered into a flat position. | accessdata.fda.gov |
| March 19, 2010 | 55139 | Not yet classified | Terminated | Stryker Atlas Transport Stretcher with Zoom, Model 660Z, Stryker Medical, Portage, MI | The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring. | accessdata.fda.gov |
| February 26, 2010 | 54265 | Not yet classified | Terminated | Eye surgery stretcher with crank fowler, model 1069 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: A stretcher used for eye surgery. | The fowler of the bed is raised by a crank. The crank cosnsists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inopperable over time wit | accessdata.fda.gov |
| September 2, 2009 | 53251 | Not yet classified | Terminated | Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251. | The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury. | accessdata.fda.gov |
| August 10, 2009 | 52230 | Not yet classified | Terminated | Stryker Epic II critical care bed, 115v, Stryker Medical, Portage, MI; Model 2030. Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting. | The backrest of the bed may not stay in an upright position (may drift down when left raised). | accessdata.fda.gov |
| August 10, 2009 | 52229 | Not yet classified | Terminated | Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 734. Wheeled hospital stretcher. | The brake/steer pedal may seize, resulting in the brakes not working. | accessdata.fda.gov |
| February 27, 2009 | 51223 | Not yet classified | Terminated | Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050. | The head section backrest (fowler) may not raise up, or, if up, may drop suddenly due to wearing out of the actuator threads on the fowler. | accessdata.fda.gov |
| January 5, 2009 | 49610 | Not yet classified | Terminated | Stryker InTouch 1.0 Critical Care Bed; Model 2130. The device is intended to be used as an Intensive Care Unit bed. | The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. | accessdata.fda.gov |
| November 18, 2008 | 50178 | Not yet classified | Terminated | Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251. | Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation. | accessdata.fda.gov |
| February 1, 2008 | 45908 | Not yet classified | Terminated | Stryker Medical Secure II Med/Surg Bed, 115 V, Stryker Medical, Portage, MI.; Model 3002. | The brakes may not have adequate holding power to lock the bed in place. | accessdata.fda.gov |
| November 2, 2007 | 45445 | Not yet classified | Terminated | Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002 | Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated 2) a battery charging defect which may result in a depletion of battery power 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access 4) beds equipped with zoom drive systems may h | accessdata.fda.gov |
| May 7, 2007 | 37978 | Not yet classified | Terminated | Stryker Medical -Wheeled Electric Stretcher, Model 1550 (with and without scales) | The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists. | accessdata.fda.gov |
| August 29, 2006 | 36149 | Not yet classified | Terminated | Stryker Power-PRO Powered Ambulance Cot, Model 6500. | The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out. | accessdata.fda.gov |
| May 15, 2006 | 35536 | Not yet classified | Terminated | Stryker Trio Mobile Surgery Platform; Model 1033. | An incorrect pin may have been used during assembly and therefore the device may give way during use. | accessdata.fda.gov |
| January 17, 2006 | 34486 | Not yet classified | Terminated | Stryker Epic Critical Care Bed; Model 2030. | The bed exit may not alarm as appropriate. | accessdata.fda.gov |
| March 31, 2005 | 31702 | Not yet classified | Terminated | Stryker brand Birthing Bed; Model 4701. | Trendelenburg and reverse trendelenburg features may not function. | accessdata.fda.gov |
| November 15, 2004 | 37214 | Not yet classified | Terminated | Stryker Zoom (Atlas) powered patient transport stretcher, Model 660, Stryker Medical, Portage, MI 49002 | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. | accessdata.fda.gov |
| August 17, 2004 | 29864 | Not yet classified | Terminated | Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092. | Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop. | accessdata.fda.gov |
| January 26, 2004 | 28135 | Not yet classified | Terminated | Stryker brand Adel maternity bed, model 4700, with night light. | A potential shock hazard exists if the night light is damaged. | accessdata.fda.gov |
| December 30, 2003 | 27990 | Not yet classified | Terminated | Stryker brand Synergy extended stay stretcher; model 1050 | Users may be pinched in the siderail assembly when raising or lowering the siderail. | accessdata.fda.gov |
| December 1, 2003 | 27824 | Not yet classified | Terminated | Stryker brand Model 1550 Synergy Extended Stay Stretcher | The user may be pinched by the siderail when raising or lowering the siderail. | accessdata.fda.gov |
| May 1, 2003 | 26325 | Not yet classified | Terminated | Stryker Secure II hospital bed; model 3002. | A wire may break at the crimp and present a potential electric shock hazard. | accessdata.fda.gov |
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Updated March 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.