3M AttestRecalls & reported problems across all models
3m Company · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one 3M Attest model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 5 models of 3M Attest by 3m Company in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between May 5, 2023 and May 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
3M Attest recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 22, 2023Open, Classified
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 132C and 135C.
Z-2639-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 6, 2023Open, Classified
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.
Z-1610-2023 · Root cause: Process control · Recall details · FDA record ↗
- Apr 6, 2023Open, Classified
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.
Z-1609-2023 · Root cause: Process control · Recall details · FDA record ↗
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1794-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported 3M Attest problems
Device problems
- Material Deformation1
Patient problems
- Insufficient Information1
3M Attest models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3M™ Attest™ 1243AIndicator, physical/chemical sterilization process1 recall0 reports
- 3M™ Attest™ 1243BIndicator, physical/chemical sterilization process1 recall0 reports
- 3M™ Attest™ 41482VIndicator, Biological Sterilization Process1 recall0 reports
- 3M™ Attest™ 1348A Chemical Vapor Sterilization Multivariable Chemical Indicator1 recall0 reports
- 3M™ Attest™ 1243REIndicator, Physical/Chemical Sterilization Process1 report
Recent 3M Attest adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2023Material Deformation
STERILE PROCESSING REPORTED HAVING INTERMITTENT ISSUES WITH THE 3M ATTEST CHEMICAL INTEGRATORS (LOT # TD122025, REF# (B)(4)) NOT PASSING THEIR SETS, WITH TWO OF THE SAME LOT# IN A SET. ONE WILL PASS AND THE OTHER WILL NOT PASS. UPON INSPECTING THE INDICATORS, IT WAS NOTED THAT THE INK CARTRIDGE FROM THE ONE THAT DOESN'T PASS IS CONCAVED, WHILE THE ONE THAT DEPLOYED INK APPROPRIATELY DOESN'T LOOK CONCAVE. 3 SETS HAVE RECENTLY HAD THIS ISSUE. MANUFACTURER RESPONSE FOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS, 3M ATTEST (PER SITE REPORTER). THE HOSPITAL'S 3M REP WAS NOTIFIED. NO RESPONSE RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 16875472 ↗
Other 3m Company products
- Steri-Drape11 models · 7 reports · 8 recalls
- 3M Steri-Drape4 models · 0 reports · 4 recalls
- Ranger10 models · 176 reports
- 3M Ranger3 models · 73 reports · 1 recall
- Attest2 models · 0 reports · 2 recalls
- 3M Red Dot8 models · 16 reports · 1 recall
- Fast Release Varnish2 models · 2 reports · 1 recall
- Comply3 models · 1 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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