Browse Device Recalls

39 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 39 FDA device recalls.

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DateProductReasonClassFirm
Nov 22, 2024 Clarity Precision Grip Attachments, for use in orthodontic treatment. Part... Attachments may not mate with the tooth as intended in the digital treatment design. Class II 3M Company - Health Care Business
Aug 14, 2024 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R Contamination with foreign substance matter Class II 3M Company - Health Care Business
Mar 20, 2024 3M Durapore Surgical Tape, Catalog Number 1538-118 Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled w... Class II 3M Company - Health Care Business
Feb 20, 2024 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; ... Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top fil... Class II 3M Company - Health Care Business
Jan 12, 2024 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with u... 3M has added the following cautionary statement regarding the use of the product: "Caution - T... Class II 3M Company - Health Care Business
Jan 12, 2024 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with u... 3M has added the following cautionary statement regarding the use of the product: "Caution - T... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qu... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designe... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualif... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Apr 6, 2023 3M Attest Steam Chemical Integrators, REF 1243A 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... Class II 3M Company - Health Care Business
Apr 6, 2023 3M Attest Steam Chemical Integrators, REF 1243B 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and Janua... Class II 3M Company - Health Care Business
Oct 6, 2021 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catal... Potential for breakage of the ECG electrode carbon stud from the eyelet. Class II 3M Company - Health Care Business
Sep 15, 2020 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to... Corrosion could cause performance failures in the product. Class II 3M Company - Health Care Business
Sep 15, 2020 Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage... Corrosion could cause performance failures in the product. Class II 3M Company - Health Care Business
Sep 15, 2020 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to b... Corrosion could cause performance failures in the product. Class II 3M Company - Health Care Business
Sep 15, 2020 Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage... Corrosion could cause performance failures in the product. Class II 3M Company - Health Care Business
Sep 15, 2020 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to b... Corrosion could cause performance failures in the product. Class II 3M Company - Health Care Business
Nov 21, 2019 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1... While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advan... Class II 3M Company - Health Care Business
Jan 14, 2019 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper C... 3M has recently received reports involving the 3MTM Surgical Clipper by Remington¿, Model 9602, o... Class II 3M Company - Health Care Business
Jul 6, 2018 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use... Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous ... Class II 3M Company - Health Care Business
Feb 2, 2018 3M Surgical Clipper Professional 9681 Failure to follow proper charging practices can result in lithium-ion battery degradation, charac... Class II 3M Company - Health Care Business
Jan 31, 2018 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 Ankl... Class II 3M Company - Health Care Business
Jan 31, 2018 ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankl... Class II 3M Company - Health Care Business
Jan 23, 2018 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 6... Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and ... Class II 3M Company - Health Care Business
Jan 23, 2018 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket,... Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and ... Class II 3M Company - Health Care Business
Nov 1, 2017 ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014... Mold was found on the non-patient contact surfaces of the product and was identified as Aspergi... Class II 3M Company - Health Care Business
Oct 17, 2017 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors... During a recent investigation, 3M confirmed that a programming translation error could occur in a... Class II 3M Company - Health Care Business
May 22, 2017 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger P... It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber... Class II 3M Company - Health Care Business
Oct 26, 2016 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Univer... 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (proces... Class II 3M Company - Health Care Business
Jan 22, 2016 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can... Class II 3M Company - Health Care Business
Dec 1, 2015 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M... Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. Thi... Class II 3M Company - Health Care Business
Jun 15, 2015 Block Versions Used by Dental Offices often referred to as chairside milling:... 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate produc... Class II 3M Company - Health Care Business
Jun 9, 2014 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These device... Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product con... Class II 3M Company - Health Care Business
Mar 17, 2014 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Ste... Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospita... Class II 3M Company - Health Care Business
Nov 21, 2013 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular B... Specific lots of Imprint II and Paradigm impression material refill packs are being recalled beca... Class II 3M Company - Health Care Business
Aug 5, 2013 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and... 3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast P... Class II 3M Company - Health Care Business
Jun 5, 2013 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... Class III 3M Company - Health Care Business
Sep 13, 2012 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas S... 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilize... Class II 3M Company - Health Care Business

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.