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3M Health Care, Ltd.

Also registered as 3M Healthcare

Country not established

Devices
70
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue70

Newest first, rows 1-50 of 70

Search and filter all 70 devices
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Rows 1-50 of 70

Showing 1-50 of 70

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2003

    • 24 Oct 2003 Z-0236-04 Unclassified (pre-2012) Terminated The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation. Distribution: The product was distributed nationwide in the United States and worldwide.
    • 24 Oct 2003 Z-0237-04 Unclassified (pre-2012) Terminated The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation. Distribution: The product was distributed nationwide in the United States and worldwide.
    • 7 Apr 2003 Z-0838-03 Unclassified (pre-2012) Terminated The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used. Distribution: Procedure packs containing the drapes were shipped nationwide in United States. Submission number: K801550
    • 7 Apr 2003 Z-0839-03 Unclassified (pre-2012) Terminated The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used. Distribution: Procedure packs containing the drapes were shipped nationwide in United States.

  • 2002

    • 9 Jan 2002 Z-0779-03 Unclassified (pre-2012) Terminated Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F. Distribution: Distribution was nationwide in the United States. There were no U.S. government accounts.

Frequently asked questions

How many devices does 3M Health Care, Ltd. have in the registry?

The registry currently lists 70 devices for 3M Health Care, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list 3M Health Care, Ltd.'s devices?

Among its 50 most recently registered devices, 3M Health Care, Ltd. has devices listed in FDA 510(k) (50 devices).

What risk classes do 3M Health Care, Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for 3M Health Care, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for 3M Health Care, Ltd.?

FDA recall records list 5 recalls initiated by 3M Health Care, Ltd., the most recent initiated on 24 Oct 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from 3M Health Care, Ltd. in the registry?

The most recently registered devices listed for 3M Health Care, Ltd. include MODEL 480CM INFUSION PUMP, MODIFICATION, 3M PREVENTION FABRIC SURGICAL GOWN #78XX, 3M PRECISE BRAND INTERNAL SURGICAL STAPLES and 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS.

Generated automatically from registry data and not verified by a human reviewer.