3M Company - Health Care Business
Complete recall history across all FDA and CPSC categories — 40 total recalls
Recall Summary
3M Company - Health Care Business appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (1)
FDA drug safety enforcement actions by 3M Company - Health Care Business
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 6, 2015 | DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isop... | Chemical contamination: Product may be contaminated with a toxic compound. | Class II |
Device Recalls (39)
FDA medical device enforcement actions by 3M Company - Health Care Business
| Date | Product | Reason | Class |
|---|---|---|---|
| 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 ... | Class II |
| Aug 14, 2024 | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R | Contamination with foreign substance matter | Class II |
| Mar 20, 2024 | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were i... | Class II |
| 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,... | Class II |
| 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 prod... | Class II |
| 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 prod... | Class II |
| 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),... | Class II |
| 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),... | Class II |
| 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),... | Class II |
| 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),... | Class II |
| Apr 6, 2023 | 3M Attest Steam Chemical Integrators, REF 1243A | 3M Attest Steam Chemical Integrators with dates of manufacture between Novemb... | Class II |
| Apr 6, 2023 | 3M Attest Steam Chemical Integrators, REF 1243B | 3M Attest Steam Chemical Integrators with dates of manufacture between Novemb... | Class II |
| 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 |
| 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 |
| Sep 15, 2020 | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage... | Corrosion could cause performance failures in the product. | Class II |
| 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 |
| Sep 15, 2020 | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage... | Corrosion could cause performance failures in the product. | Class II |
| 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 |
| 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 ... | Class II |
| 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 Remin... | Class II |
| 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 resulti... | Class II |
| Feb 2, 2018 | 3M Surgical Clipper Professional 9681 | Failure to follow proper charging practices can result in lithium-ion battery... | Class II |
| 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 AC... | Class II |
| 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 AC... | Class II |
| 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 Blanke... | Class II |
| 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 Blanke... | Class II |
| 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 id... | Class II |
| Oct 17, 2017 | 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors... | During a recent investigation, 3M confirmed that a programming translation er... | Class II |
| 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, pro... | Class II |
| 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 uninten... | Class II |
| Jan 22, 2016 | 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. | 3M discovered a valve with incorrectly labeled "input" and "output" orientati... | Class II |
| 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.... | Class II |
| 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 ... | Class II |
| 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 stateme... | Class II |
| 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 Oxi... | Class II |
| 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... | Class II |
| 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" Scotchcas... | Class II |
| 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 Crow... | Class III |
| 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 a... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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