Data / Medical devices / United States / SunMed Group Holdings, LLC
SunMed Group Holdings, LLC: FDA-registered device maker in Grand Rapids, MI, United States, 171 510(k) clearances and 1 PMA approval
SunMed Group Holdings, LLC is registered with the FDA (registration 1314417) in Grand Rapids, MI, United States. It lists 132 device types. The FDA files 171 510(k) clearances and 1 PMA approval under its listings, the newest dated November 12, 2024. 26 recall events name it as the recalling firm (5 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1314417
- Address
- 2710 Northridge Dr NW Ste A, Grand Rapids, MI, United States, 49544
- Owner or operator
- SunMed Group Holdings, LLC dba AirLife (10044795)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- August 1, 2013
- Registered through
- 2027
- Brand names listed
- "Blue" Latex Robertazzi Nasopharyngeal Airway, 1200 Infusion System, 500 Series Nebulizer, 8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000, ACCESSORY, SURGICAL APPAREL, AMBU CO2 Easy, AMBU Pedi CO2 Easy, ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE and more
Devices it lists
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. Newest 100 of 171.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 12, 2024 | K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | CCK | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| August 10, 2023 | K231380 | AirLife DuoTherm Humidification System | BTT | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| August 3, 2023 | K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | BTT | Substantially Equivalent | Hometa, Inc. | accessdata.fda.gov |
| January 10, 2020 | K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff | BTR | Substantially Equivalent | Salter Labs, Inc. | accessdata.fda.gov |
| August 16, 2019 | K190853 | Vyntus BODY | BZC | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| May 23, 2019 | K182362 | MaxCap Ped and MaxCap Neo | CCK | Substantially Equivalent | Maxtec, LLC | accessdata.fda.gov |
| November 30, 2018 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | BZC | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| November 16, 2018 | K173373 | SafeT T-Piece Resuscitator | BTL | Substantially Equivalent | Ventlab, LLC | accessdata.fda.gov |
| June 20, 2018 | K173147 | SuperNO2VA Et Device | CCK | Substantially Equivalent | Revolutionary Medical Devices, Inc. | accessdata.fda.gov |
| October 13, 2017 | K163277 | SuperNO2VA Device | BSJ | Substantially Equivalent | Revolutionary Medical Devices, Inc. | accessdata.fda.gov |
| September 21, 2017 | K161719 | Salter Labs Bubble Humidifier | BTT | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| September 14, 2017 | K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | BZE | Substantially Equivalent | Vyaire Medical | accessdata.fda.gov |
| December 14, 2016 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| August 25, 2016 | K160764 | AirLife Autofill Humidification Chamber | BTT | Substantially Equivalent | Carefusion 2200, Inc. | accessdata.fda.gov |
| July 7, 2016 | K153234 | AirLife Adult Heated Wire Circuit | BZE | Substantially Equivalent | Carefusion, Inc. | accessdata.fda.gov |
| May 13, 2016 | K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator | BXN | Substantially Equivalent | Easy Med Instrument Co., Ltd. | accessdata.fda.gov |
| April 15, 2016 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | MNR | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| January 21, 2016 | K151303 | AirLife Infant Heated Wire Circuit | BZE | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| January 20, 2016 | K151959 | AirLife Infant Single Limb Heated Wire Circuit | BZE | Substantially Equivalent | Carefusion, Inc. | accessdata.fda.gov |
| August 14, 2015 | K150810 | Vyntus / SentrySuite Product Line | BZC | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| March 28, 2014 | K133540 | FLOCAP | CCK | Substantially Equivalent | Maxtec, Inc. | accessdata.fda.gov |
| December 31, 2013 | K133806 | M1 CAPNOGRAPHY MASK | CCK | Substantially Equivalent | Monitor Mask, Inc. | accessdata.fda.gov |
| October 30, 2013 | K131719 | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | HLJ | Substantially Equivalent | Medical Devices (Pvt) , Ltd. | accessdata.fda.gov |
| June 5, 2013 | K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Inspirx, Inc. | accessdata.fda.gov |
| April 25, 2013 | K123527 | AIRLIFE | CAF | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| March 28, 2013 | K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | BXN | Substantially Equivalent | Sunmed, LLC | accessdata.fda.gov |
| December 6, 2012 | K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | CAH | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| September 14, 2012 | K121625 | LULLABY TM WARMER | FMT | Substantially Equivalent | Wipro GE Healthcare Private, Ltd. | accessdata.fda.gov |
| July 13, 2012 | K112840 | CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR | CCK | Substantially Equivalent | Seebreath AB | accessdata.fda.gov |
| May 24, 2012 | K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | CAP | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| May 11, 2012 | K113333 | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS | BTR | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| May 4, 2012 | K120518 | END TIDAL CO2 NASAL CANNULA | CCK | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| February 10, 2012 | K113542 | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) | BTT | Substantially Equivalent | Salter Labs, Arvin Facility | accessdata.fda.gov |
| November 23, 2011 | K112564 | QUIXIE NEBULIZER | CAF | Substantially Equivalent | Odyssey Medical Technologies | accessdata.fda.gov |
| September 12, 2011 | K110713 | WATERPAP VALVE | BYE | Substantially Equivalent | Airways Development, LLC | accessdata.fda.gov |
| August 12, 2011 | K102120 | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 | CBK | Substantially Equivalent | Hsiner Co., Ltd. | accessdata.fda.gov |
| July 22, 2011 | K102674 | CUFF SENTRY | BSK | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| March 24, 2011 | K101721 | WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA | BTO | Substantially Equivalent | Regulatory and Marketing Services, Inc. | accessdata.fda.gov |
| January 27, 2011 | K093617 | VENTLAB 6000 SERIES HUMIDIFIER | BTT | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| August 3, 2010 | K100288 | NEOMED ENTERAL ONLY EXTENSION SET | KNT | Substantially Equivalent | Neomed, Inc. | accessdata.fda.gov |
| June 3, 2010 | K100546 | PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE | BTR | Substantially Equivalent | Parkermedicalinc | accessdata.fda.gov |
| March 11, 2010 | K092886 | WELL LEAD ENDOBRONCHIAL TUBES | CBI | Substantially Equivalent | Well Lead Instruments | accessdata.fda.gov |
| December 10, 2009 | K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE | CCK | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| November 18, 2009 | K090915 | STERILE WATER FOR INHALATION FLEX BAG, USP | BTT | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| June 25, 2009 | K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. | CAF | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| May 22, 2009 | K091250 | DIAGNOSTIC CATHETER SYSTEM | EOQ | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| December 30, 2008 | K083765 | MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL | FPA | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| December 18, 2008 | K083042 | WOUND FLUSH, STERILE WATER & NORMAL SALINE | FRO | Substantially Equivalent | Nurse Assist, Inc. | accessdata.fda.gov |
| October 15, 2008 | K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | BTM | Substantially Equivalent | Galemed Corp. | accessdata.fda.gov |
| October 8, 2008 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| April 22, 2008 | K080821 | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| March 26, 2008 | K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | CCK | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| August 23, 2007 | K072220 | PEDI CO2 EASY | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| August 13, 2007 | K070371 | FINGERTIP PULSE OXIMETER MD300C | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| August 10, 2007 | K072119 | AIRLIFE NEBULIZER CAP | CAF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| February 23, 2007 | K063268 | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 | BZD | Substantially Equivalent | Hsiner Co., Ltd. | accessdata.fda.gov |
| February 15, 2007 | K070128 | CO2 EASY | CCK | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| June 30, 2005 | K050803 | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES | BTR | Substantially Equivalent | Vitaid, Ltd. | accessdata.fda.gov |
| March 1, 2005 | K043120 | MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER | CAH | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| February 18, 2005 | K042683 | WELL LEAD ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| February 17, 2005 | K042684 | WELL LEAD TRACHEOSTOMY TUBE | BTO | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| June 10, 2004 | K041418 | AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER | CAF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| June 3, 2004 | K040726 | VENTLAB NASAL CPAP CANNULA | BZD | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| May 13, 2004 | K033008 | AIR SAFETY HEPA AND NON-HEPA FILTERS | CAH | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
| February 13, 2004 | K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | BZD | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| July 7, 2003 | K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 | CAH | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| June 25, 2003 | K030990 | DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR | CAH | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| June 20, 2003 | K031653 | DATEX-OHMEDA HMEF 750 | CAH | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| May 2, 2003 | K023673 | AIRLIFE DEMAND NASAL CANNULA | NFB | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| May 1, 2003 | K023602 | SMALL VOLUME NEBULIZER | CAF | Substantially Equivalent | Allegiance Healthcare Corporation | accessdata.fda.gov |
| April 22, 2003 | K030943 | MODIFICATION TO HIOX | CBP | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| November 27, 2002 | K023641 | DATEX-OHMEDA HMEF MINI | CAH | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| August 30, 2002 | K021265 | DATEX-OHMEDA HMEF 500 | CAH | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| August 22, 2002 | K022402 | DISPOSABLE PRESSURE MANOMETER | CAP | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| February 11, 2002 | K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| September 18, 2001 | K012842 | V*CARE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| June 8, 2001 | K011132 | AIRLIFE HEPA FILTER | CAH | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| March 30, 2000 | K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS | BZE | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| December 10, 1999 | K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS | BZE | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| September 24, 1999 | K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| May 13, 1999 | K991484 | AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 | BTT | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| February 11, 1999 | K990098 | VENTLAB VERIFY II | BTR | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| November 13, 1998 | K970811 | DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN | JOH | Substantially Equivalent | Pneumocare, Inc. | accessdata.fda.gov |
| September 18, 1998 | K982215 | MANUAL RESUSCITATOR WITH ACE | BTM | Substantially Equivalent | Medical Marketing Concepts | accessdata.fda.gov |
| August 24, 1998 | K981944 | BREATHERITE | CAF | Substantially Equivalent | Ventlab Corp. | accessdata.fda.gov |
| October 27, 1997 | K971259 | COMBIPORT FLUID LAVAGE DEVICE | KDH | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 18, 1997 | K970359 | COMBIPROT EMERGENCY ENFUSION DEVICE | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| February 21, 1997 | K962850 | TUM-E-VAC | KDH | Substantially Equivalent | Ethox Corp. | accessdata.fda.gov |
| January 14, 1997 | K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | BZE | Substantially Equivalent | Marquest Medical Products, Inc. | accessdata.fda.gov |
| November 13, 1996 | K964204 | ENGSTROM HMEF 1000 | CAH | Substantially Equivalent | Datex Engstrom AB | accessdata.fda.gov |
| October 22, 1996 | K962879 | SALTERLABS 8660 SERIES NEBULIZER | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| October 18, 1996 | K961838 | RESPIRGARD II, SPIROGARD | CAH | Substantially Equivalent | Marquest Medical Products, Inc. | accessdata.fda.gov |
| August 15, 1996 | K962161 | BAXTER NEBULIZER CAP MODEL 2D0868 | CAF | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| August 13, 1996 | K961867 | PEEP VALVE | BYE | Substantially Equivalent | Medical Marketing Concepts | accessdata.fda.gov |
| July 31, 1996 | K962079 | HUMIDIFIER ADAPTER | BTT | Substantially Equivalent | Automatic Liquid Packaging, Inc. | accessdata.fda.gov |
| July 16, 1996 | K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | CAF | Substantially Equivalent | Salter Labs | accessdata.fda.gov |
| February 29, 1996 | K953546 | MANUAL PULMONARY RESUSICITATOR | BTM | Substantially Equivalent | Medical Marketing Concepts | accessdata.fda.gov |
| June 2, 1995 | K951047 | BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA | CAH | Substantially Equivalent | Vital Signs, Inc. | accessdata.fda.gov |
| November 22, 1994 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | BTY | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| October 13, 1994 | K943600 | UNIHEART | CAF | Substantially Equivalent | Vortran Medical Technology 1, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 29, 1991 | P890057 | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR | LSZ | 22 | July 23, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2025 | 98208 | Class I | Ongoing | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference t | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | accessdata.fda.gov |
| May 15, 2025 | 96891 | Class I | Ongoing | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically d | The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the O | accessdata.fda.gov |
| May 1, 2025 | 96801 | Class I | Ongoing | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death. | accessdata.fda.gov |
| October 11, 2023 | 93237 | Class II | Ongoing | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | accessdata.fda.gov |
| December 22, 2022 | 91391 | Class II | Ongoing | Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405 | There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter. | accessdata.fda.gov |
| September 8, 2022 | 90834 | Class II | Terminated | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 | The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle. | accessdata.fda.gov |
| May 24, 2018 | 80201 | Class II | Terminated | STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | accessdata.fda.gov |
| March 15, 2016 | 73766 | Class II | Terminated | STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly | Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation. | accessdata.fda.gov |
| January 5, 2016 | 73130 | Class II | Terminated | T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment. | Reports that the T-piece does not fit on the nebulizer. | accessdata.fda.gov |
| August 4, 2015 | 71909 | Class II | Terminated | NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment | The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment. | accessdata.fda.gov |
| June 25, 2014 | 68701 | Class II | Terminated | Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use. | The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather. | accessdata.fda.gov |
| May 16, 2014 | 68242 | Class I | Terminated | Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, | The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim. | accessdata.fda.gov |
| November 1, 2013 | 66720 | Class II | Terminated | Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line. | It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length. | accessdata.fda.gov |
| July 11, 2012 | 63347 | Class I | Terminated | Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intend | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | accessdata.fda.gov |
| May 30, 2012 | 62272 | Class II | Terminated | Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia. | A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector. | accessdata.fda.gov |
| December 7, 2011 | 60658 | Not yet classified | Terminated | ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock con | Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors). | accessdata.fda.gov |
| October 21, 2011 | 60270 | Not yet classified | Terminated | Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that c | A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak. | accessdata.fda.gov |
| April 19, 2011 | 58564 | Not yet classified | Terminated | Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help. | One complaint received of product in box different from what was on label. | accessdata.fda.gov |
| April 19, 2011 | 58563 | Not yet classified | Terminated | Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula. Single Patient Use. Do not Steril | Complaint received that the product in the box was different from labeled product. | accessdata.fda.gov |
| March 25, 2011 | 60374 | Not yet classified | Terminated | TUM-E-VAC REF 2075, Rx ONLY, NON STERILE --- Ethox International, Buffalo, NY 14204, USA --- Intended use: gastric lavage | Ethox Tum-E-Vac Gastric Lavage Kit #2075, Lot Number 031123255 was labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton was labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date. | accessdata.fda.gov |
| March 25, 2011 | 58454 | Not yet classified | Terminated | Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy. | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. | accessdata.fda.gov |
| December 21, 2010 | 57504 | Not yet classified | Terminated | ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connector | The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment. | accessdata.fda.gov |
| December 5, 2007 | 48958 | Not yet classified | Terminated | Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk. | During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly. | accessdata.fda.gov |
| April 27, 2007 | 50092 | Not yet classified | Terminated | Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20. | A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth. | accessdata.fda.gov |
| March 26, 2004 | 28689 | Not yet classified | Terminated | STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 270 | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | accessdata.fda.gov |
| April 15, 2003 | 26369 | Not yet classified | Terminated | V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use st | Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Emergency, Manual (Resuscitator)
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Mask, Oxygen
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Clip, Nose
Updated January 28, 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.