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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.