Data / Medical devices / United States / 3M Company
3M Company: FDA-registered device maker in Saint Paul, MN, United States, 7 510(k) clearances
3M Company is registered with the FDA (registration 2110898) in Saint Paul, MN, United States. It lists 24 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 10, 2017. 43 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2110898
- Address
- 2510 Conway Ave., Saint Paul, MN, United States, 55144
- Owner or operator
- 3M COMPANY (2110898)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 15, 1992
- Registered through
- 2026
- Brand names listed
- 3M, 3M Respirator, 3M STOMASEAL ADHESIVE DIS, 3M, BANDAGE, ELASTIC, BINDER, ABDOMINAL, Dressing, Wound, Hydrophilic, Dressing, wound, occlusive and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Colostomy, Disposable | EZS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Binder, Abdominal | FSD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Fertility Diagnostic, Proceptive | LHD | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Specification developer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Specification developer | accessdata.fda.gov |
| Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | NZJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Splint, Clavicle | IQJ | 1 | Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 10, 2017 | K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | MSH | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| December 20, 2012 | K123085 | FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE | DWL | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| December 18, 2009 | K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | DWL | Substantially Equivalent | Beiersdorf, Inc. | accessdata.fda.gov |
| May 8, 2007 | DEN060009 | 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR | NZJ | Unknown | 3M Company | accessdata.fda.gov |
| February 23, 2007 | K063023 | 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 | MSH | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| May 1, 1996 | K955382 | 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 | FXX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| June 15, 1995 | K945427 | B-D DIGITAL THERMOMETER | LHD | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 22, 2025 | 97174 | Class II | Ongoing | 3M Ranger Irrigation Fluid Warming Set, REF 24750 | Notice was issued to clarify flow rates related to the inlet fluid temperature. | accessdata.fda.gov |
| April 10, 2025 | 96841 | Class I | Ongoing | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 | Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets. | accessdata.fda.gov |
| November 22, 2024 | 95828 | Class II | Ongoing | Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: | Attachments may not mate with the tooth as intended in the digital treatment design. | accessdata.fda.gov |
| August 14, 2024 | 95273 | Class II | Ongoing | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R | Contamination with foreign substance matter | accessdata.fda.gov |
| March 20, 2024 | 94259 | Class II | Ongoing | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years. | accessdata.fda.gov |
| February 20, 2024 | 94039 | Class II | Ongoing | 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary | Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner. | accessdata.fda.gov |
| January 12, 2024 | 93825 | Class II | Ongoing | 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L | 3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41C (105.8F). " Do not leave the c | accessdata.fda.gov |
| August 22, 2023 | 92915 | Class II | Ongoing | 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles | Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132C and 135C. | accessdata.fda.gov |
| April 6, 2023 | 92041 | Class II | Ongoing | 3M Attest Steam Chemical Integrators, REF 1243A | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle. | accessdata.fda.gov |
| October 6, 2021 | 88763 | Class II | Terminated | 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, | Potential for breakage of the ECG electrode carbon stud from the eyelet. | accessdata.fda.gov |
| September 15, 2020 | 86519 | Class II | Terminated | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 | Corrosion could cause performance failures in the product. | accessdata.fda.gov |
| November 21, 2019 | 84376 | Class II | Terminated | 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136 | While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which coul | accessdata.fda.gov |
| January 14, 2019 | 81933 | Class II | Terminated | 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal. | 3M has recently received reports involving the 3MTM Surgical Clipper by Remington, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter. | accessdata.fda.gov |
| July 6, 2018 | 80730 | Class II | Terminated | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tu | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. | accessdata.fda.gov |
| February 2, 2018 | 79289 | Class II | Terminated | 3M Surgical Clipper Professional 9681 | Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy. | accessdata.fda.gov |
| January 31, 2018 | 79051 | Class II | Terminated | FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 | 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement. | accessdata.fda.gov |
| January 23, 2018 | 79002 | Class II | Terminated | 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature manageme | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. | accessdata.fda.gov |
| November 1, 2017 | 78444 | Class II | Terminated | ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9 | Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus. | accessdata.fda.gov |
| October 17, 2017 | 78327 | Class II | Terminated | 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) | During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature. | accessdata.fda.gov |
| May 22, 2017 | 77399 | Class II | Terminated | 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required. | It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification. | accessdata.fda.gov |
| October 26, 2016 | 75644 | Class II | Terminated | 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most el | 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product. This may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of | accessdata.fda.gov |
| January 22, 2016 | 73117 | Class II | Terminated | 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. | 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle. | accessdata.fda.gov |
| December 1, 2015 | 72780 | Class II | Terminated | 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM. | Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe. | accessdata.fda.gov |
| June 15, 2015 | 71456 | Class II | Terminated | Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with | 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers. | accessdata.fda.gov |
| June 9, 2014 | 68415 | Class II | Terminated | 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle. | Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been rep | accessdata.fda.gov |
| March 17, 2014 | 67716 | Class II | Terminated | 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is int | Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in | accessdata.fda.gov |
| November 21, 2013 | 66944 | Class II | Terminated | 3M ESPE Imprint II Regular Body, Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are com | Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression. | accessdata.fda.gov |
| August 5, 2013 | 66052 | Class II | Terminated | 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization. | 3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet cond | accessdata.fda.gov |
| June 5, 2013 | 66509 | Class III | Terminated | 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior te | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns. | accessdata.fda.gov |
| September 13, 2012 | 63214 | Class II | Terminated | 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for ind | 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim. | accessdata.fda.gov |
| October 6, 2010 | 57115 | Not yet classified | Terminated | 3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. Unitek" Primary Stainless Steel Crowns- Series UL3 and UR3 Product Code 900223, 900213, 902150 | Unitek Stainless Steel Permanent Crowns with product Codes 902150, 900213, and 900223, is mislabeled. The crown contained within the package is incorrectly labeled; series UL3 crowns are labeled series UR3 and vice versa. The lid of the package correctly identified the product number and lot. This mislabeling could result in placement on the right side of a | accessdata.fda.gov |
| July 27, 2010 | 56488 | Not yet classified | Terminated | 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring. | The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response. | accessdata.fda.gov |
| January 29, 2010 | 54640 | Not yet classified | Terminated | 3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd. | Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the dialysis needle may loosen and could then dislodge. In the interim, please offer 3M Micropore Surgical Tape, 1 inch x 10 ya | accessdata.fda.gov |
| March 19, 2008 | 46950 | Not yet classified | Terminated | 3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that tu | A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate. | accessdata.fda.gov |
| October 17, 2007 | 45951 | Not yet classified | Terminated | 3M ESPE Unitek Stainless Steel Permanent Molar Crowns, Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000. | Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns. | accessdata.fda.gov |
| August 9, 2006 | 36180 | Not yet classified | Terminated | 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. | 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing. | accessdata.fda.gov |
| February 9, 2006 | 34633 | Not yet classified | Terminated | 3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped & sterile. catalog # 434-10. 3M Consumer Health Care, St. Paul, MN 55144-1000. Made in USA. UPC 05113166774. | After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product. | accessdata.fda.gov |
| November 5, 2004 | 30407 | Not yet classified | Terminated | 3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with paper cover) contains no la | Mislabeled - Nexcare Holdfast Roll Gauze were not sterilized, the product is labeled with 'Sterility Guaranteed Unless Package is Opened or Damaged' | accessdata.fda.gov |
| September 30, 2004 | 30137 | Not yet classified | Terminated | NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V | Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection. | accessdata.fda.gov |
| February 27, 2004 | 28411 | Not yet classified | Terminated | 3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box | The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout at 3 hours. | accessdata.fda.gov |
| October 24, 2003 | 27465 | Not yet classified | Terminated | 3M Attest 1264 Biological Indicators, in boxes of 100 per box | The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation. | accessdata.fda.gov |
| April 7, 2003 | 25979 | Not yet classified | Terminated | 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ | The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used. | accessdata.fda.gov |
| January 9, 2002 | 25868 | Not yet classified | Terminated | N/A | Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Support, Arm
- All makers of Device, Fertility Diagnostic, Proceptive
- All makers of Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- All makers of Joint, Ankle, External Brace
- All makers of Joint, Knee, External Brace
Updated August 1, 2025. 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.