Recall Register

3M Company - Health Care Business: FDA recalls

FDA enforcement reports name 3M Company - Health Care Business as the recalling firm in 29 events. The events have 40 product records. The recalls started from 2012 to 2024.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

29 events, newest first.

FDA enforcement events of 3M Company - Health Care Business
InitiatedProduct (first record)TypeClassRecordsStatus
22 Nov 2024Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837DeviceClass II1Ongoing
14 Aug 20243M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658RDeviceClass II1Ongoing
20 Mar 20243M Durapore Surgical Tape, Catalog Number 1538-118DeviceClass II1Ongoing
20 Feb 20243M 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 primary carton, and 4 primary cartons per shipper box.DeviceClass II1Ongoing
12 Jan 20243M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661LDeviceClass II2Ongoing
22 Aug 20233M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cyclesDeviceClass II4Ongoing
6 Apr 20233M Attest Steam Chemical Integrators, REF 1243ADeviceClass II2Ongoing
6 Oct 20213M 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, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam…DeviceClass II1Terminated
15 Sep 2020Novaplus 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 (1000 electrodes total).DeviceClass II5Terminated
21 Nov 20193M 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-136DeviceClass II1Terminated
14 Jan 20193M(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.DeviceClass II1Terminated
6 Jul 20183M 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 dentinal tubules and treatment of hypersensitive teeth.DeviceClass II1Terminated
2 Feb 20183M Surgical Clipper Professional 9681DeviceClass II1Terminated
31 Jan 2018FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6DeviceClass II2Terminated
23 Jan 20183M 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 management system can be used to provide patient thermal comfort when conditions exist that may cause…DeviceClass II2Terminated
1 Nov 2017ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9DeviceClass II1Terminated
17 Oct 20173M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)DeviceClass II1Terminated
22 May 20173M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.DeviceClass II1Terminated
26 Oct 20163M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is…DeviceClass II1Terminated
22 Jan 20163M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.DeviceClass II1Terminated
1 Dec 20153M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.DeviceClass II1Terminated
6 Aug 2015DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0…DrugClass II1Terminated
15 Jun 2015Block Versions Used by Dental Offices often referred to as chairside milling: Lava„ Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for…DeviceClass II1Terminated
9 Jun 20143M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.DeviceClass II1Terminated
17 Mar 20143M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.DeviceClass II1Terminated
21 Nov 20133M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown…DeviceClass II1Terminated
5 Aug 20133M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.DeviceClass II1Terminated
5 Jun 20133M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.DeviceClass III1Terminated
13 Sep 20123M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

3M Company - Health Care Business: events for each product type
TypeEvents
Device28
Drug1
3M Company - Health Care Business: events in each class
ClassEvents
Class II28
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
7

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of 3M Company - Health Care Business, by the year that the recall started. The largest year is 2024, with 5 events.

Official channels

Cite this page

Recall Register. 3M Company - Health Care Business: FDA recalls. https://recallregister.com/firm/3m-company-health-care-business/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MN

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of 3M Company - Health Care Business have?
Class II: 28 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of 3M Company - Health Care Business have?
Device: 28 events. Drug: 1 event.
What is the newest FDA recall of 3M Company - Health Care Business?
FDA event 95828, which the firm started on 22 Nov 2024. The first product in the record is: 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
How many FDA recalls of 3M Company - Health Care Business have the status Ongoing?
7 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.