3m Health Care Business recalls
3m Health Care Business appears in 40 official U.S. recall notices indexed by RecallRadar, most recently on 2025-01-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 40 |
|---|---|
| Published | 2012-10-17 to 2025-01-01 |
| By agency | FDA Device (39), FDA Drug (1) |
| By classification | Class II (39), Class III (1) |
| By status | terminated (28), ongoing (12) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, US, UT, VA, WA, WI, WV |
Recalls
- Clarity Precision Grip Attachments, for use in orthodontic treatment
FDA Device · Class II · 2025-01-01 · 3m Health Care Business
Reason: Attachments may not mate with the tooth as intended in the digital treatment design. - 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
FDA Device · Class II · 2024-10-16 · 3m Health Care Business
Reason: Contamination with foreign substance matter - 3M Durapore Surgical Tape, Catalog Number 1538-118
FDA Device · Class II · 2024-05-01 · 3m Health Care Business
Reason: 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. - 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile
FDA Device · Class II · 2024-04-10 · 3m Health Care Business
Reason: 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 ex… - 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
FDA Device · Class II · 2024-02-28 · 3m Health Care Business
Reason: 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 cli… - 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
FDA Device · Class II · 2024-02-28 · 3m Health Care Business
Reason: 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 cli… - 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V
FDA Device · Class II · 2023-10-04 · 3m Health Care Business
Reason: 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 biologi… - 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V
FDA Device · Class II · 2023-10-04 · 3m Health Care Business
Reason: 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 biologi… - 3M Attest Super Rapid Readout Biological Indicator, REF 1492V
FDA Device · Class II · 2023-10-04 · 3m Health Care Business
Reason: 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 biologi… - 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF
FDA Device · Class II · 2023-10-04 · 3m Health Care Business
Reason: 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 biologi… - 3M Attest Steam Chemical Integrators, REF 1243B
FDA Device · Class II · 2023-05-24 · 3m Health Care Business
Reason: 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. - 3M Attest Steam Chemical Integrators, REF 1243A
FDA Device · Class II · 2023-05-24 · 3m Health Care Business
Reason: 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. - 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989)…
FDA Device · Class II · 2021-11-10 · 3m Health Care Business
Reason: Potential for breakage of the ECG electrode carbon stud from the eyelet. - 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 elec…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business
Reason: Corrosion could cause performance failures in the product. - 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 elec…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business
Reason: Corrosion could cause performance failures in the product. - 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 el…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business
Reason: Corrosion could cause performance failures in the product. - Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monit…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business
Reason: Corrosion could cause performance failures in the product. - Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monit…
FDA Device · Class II · 2020-11-11 · 3m Health Care Business
Reason: Corrosion could cause performance failures in the product. - 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…
FDA Device · Class II · 2020-01-01 · 3m Health Care Business
Reason: 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… - 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…
FDA Device · Class II · 2019-02-06 · 3m Health Care Business
Reason: 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. - 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…
FDA Device · Class II · 2018-11-07 · 3m Health Care Business
Reason: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. - FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
FDA Device · Class II · 2018-03-21 · 3m Health Care Business
Reason: 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… - ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
FDA Device · Class II · 2018-03-21 · 3m Health Care Business
Reason: 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… - 3M Surgical Clipper Professional 9681
FDA Device · Class II · 2018-03-07 · 3m Health Care Business
Reason: 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 b… - 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is inten…
FDA Device · Class II · 2018-02-21 · 3m Health Care Business
Reason: 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 inflati… - 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is…
FDA Device · Class II · 2018-02-21 · 3m Health Care Business
Reason: 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 inflati… - ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2
FDA Device · Class II · 2018-02-14 · 3m Health Care Business
Reason: Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus. - 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
FDA Device · Class II · 2017-11-29 · 3m Health Care Business
Reason: 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. - 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure…
FDA Device · Class II · 2017-07-05 · 3m Health Care Business
Reason: It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification. - 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) P…
FDA Device · Class II · 2016-12-14 · 3m Health Care Business
Reason: 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 U… - 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL
FDA Device · Class II · 2016-05-04 · 3m Health Care Business
Reason: 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… - 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM
FDA Device · Class II · 2016-01-13 · 3m Health Care Business
Reason: 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. - DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation,…
FDA Drug · Class II · 2015-09-16 · 3m Health Care Business
Reason: Chemical contamination: Product may be contaminated with a toxic compound. - Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona…
FDA Device · Class II · 2015-07-15 · 3m Health Care Business
Reason: 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. - 3M Attest Auto-reader
FDA Device · Class II · 2014-07-16 · 3m Health Care Business
Reason: 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… - 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to ster…
FDA Device · Class II · 2014-04-09 · 3m Health Care Business
Reason: 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 t… - 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are int…
FDA Device · Class II · 2013-12-25 · 3m Health Care Business
Reason: 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. - 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional cove…
FDA Device · Class III · 2013-12-04 · 3m Health Care Business
Reason: 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. - 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet o…
FDA Device · Class II · 2013-09-25 · 3m Health Care Business
Reason: 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… - 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- a…
FDA Device · Class II · 2012-10-17 · 3m Health Care Business
Reason: 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 conta…