Saint Paul, MN, United States
3M Company - Health Care Business recalls
16 recalls recorded since 2018, most recently on 22 November 2024. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls16
Ongoing (FDA)7
Terminated or completed9
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 November 2024
- Reason
- Attachments may not mate with the tooth as intended in the digital treatment design.
- Distribution
- Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0743-2025
- Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
Ongoing Class II Medical devices
- Recall started
- 14 August 2024
- Reason
- Contamination with foreign substance matter
- Distribution
- International distribution to the country of South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0038-2025
- 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Ongoing Class II Medical devices
- Recall started
- 20 March 2024
- 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.
- Distribution
- Worldwide distribution - US Nationwide in the states of TX, NY, NH, AZ, NC, CA, IL, GA, VA, MD, FL, and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1633-2024
- 3M Durapore Surgical Tape, Catalog Number 1538-118
Ongoing Class II Medical devices
- Recall started
- 20 February 2024
- 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 excess material not being removed from the product liner.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MN, NC, NH, NY, OH, PA, TX, VA, and WA, including PR. The countries of Australia, Austria, Canada, China, Finland, Germany, Ireland, New Zealand, Norway, Poland, Sweden, and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1475-2024
- 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 primar
Ongoing Class II Medical devices
- Recall started
- 12 January 2024
- 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 clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1169-2024, Z-1170-2024
- 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
- 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L
Ongoing Class II Medical devices
- Recall started
- 22 August 2023
- 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 biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2637-2023, Z-2640-2023, Z-2638-2023, Z-2639-2023
- 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
- 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
- 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
- 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Ongoing Class II Medical devices
- Recall started
- 6 April 2023
- 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.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Australia, Bolivia, Brazil, Canada, Colombia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Poland, Saudi Arabia, Slovakia, South Korea, S
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1610-2023, Z-1609-2023
- 3M Attest Steam Chemical Integrators, REF 1243B
- 3M Attest Steam Chemical Integrators, REF 1243A
Terminated Class II Medical devices
- Recall started
- 6 October 2021
- Terminated
- 17 January 2024
- Reason
- Potential for breakage of the ECG electrode carbon stud from the eyelet.
- Distribution
- US Nationwide Distribution to states of: AL, AZ, CA, IA, IL, LA, MD, MO, NC, NJ, and OH; and OUS Foreign distribution to countries of: Australia, Bermuda, Canada, China, France, Germany, Japan, the Netherlands, Singapore, Sweden, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0188-2022
- 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,
Terminated Class II Medical devices
- Recall started
- 15 September 2020
- Terminated
- 1 February 2022
- Reason
- Corrosion could cause performance failures in the product.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0422-2021, Z-0420-2021, Z-0423-2021, Z-0419-2021, Z-0421-2021
- 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
- Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (60
- 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
- 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 (1
- 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrod
Terminated Class II Medical devices
- Recall started
- 21 November 2019
- Terminated
- 23 April 2021
- 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. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated.
- Distribution
- Nationwide, Canada, Germany, France, Switzerland, Denmark
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0719-2020
- 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
Terminated Class II Medical devices
- Recall started
- 14 January 2019
- Terminated
- 11 February 2021
- 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.
- Distribution
- US Distribution and countries Brazil and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0791-2019
- 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.
Terminated Class II Medical devices
- Recall started
- 6 July 2018
- Terminated
- 26 February 2019
- Reason
- Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
- Distribution
- US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0368-2019
- 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 dentin
Terminated Class II Medical devices
- Recall started
- 2 February 2018
- Terminated
- 2 August 2024
- 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 been associated with battery venting, which is a rapid release of battery energy.
- Distribution
- Worldwide distribution including US nationwide, including Puerto Rico. Singapore, Australia, Canada, Chile, Colombia, Costa Rica, Brazil, Dominica, Ecuador, Guatemala, UAE, Israel, Japan, Korea, Mexico, new Zealand, Paraguay, Peru, Taiwan, Uruguay, India, Bolivia, El Salvador, Saudi Arabia, and Thai
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0777-2018
- 3M Surgical Clipper Professional 9681
Terminated Class II Medical devices
- Recall started
- 31 January 2018
- Terminated
- 11 February 2021
- 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 appropriate caution statement.
- Distribution
- US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0946-2018, Z-0945-2018
- ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
- FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Terminated Class II Medical devices
- Recall started
- 23 January 2018
- Terminated
- 21 August 2020
- 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 inflation during use.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Chile, Costa Rica, Deutschland GMBH, Dominican, Ecuador, Hong Kong, Indonesia, Japan, Korea, Paraguay, Philippines, New Zealand, Shanghai, Thailand, and Uruguay.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0598-2018, Z-0599-2018
- 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 mana
- 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management
Terminated Class II Medical devices
- Recall started
- 1 November 2017
- Terminated
- 22 July 2020
- Reason
- Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
- Distribution
- AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0552-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.