ComplyRecalls & reported problems across all models
3m Company · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Comply 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
- 1
We found 3 models of Comply 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 Mar 22, 2019 and Mar 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Comply 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.
- May 25, 2022Class IIIOpen, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Comply problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient1
Comply models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comply™ 1248Indicator, physical/chemical sterilization process1 recall0 reports
- Comply™ 1248Indicator, physical/chemical sterilization process1 recall0 reports
- Comply™ 1233LFIndicator, physical/chemical sterilization process1 report
Recent Comply adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2019Incorrect, Inadequate or Imprecise Result or Readings
REPORTED THAT THE BOWIE DICK COMPLY TEST FAILED 4 TIMES IN 3 DIFFERENT STERILIZERS. ALL TESTS CAME FROM THE SAME BOX WITH THE SAME LOT #. AFTER EACH FAILURE, EACH STERILIZER WAS INSPECTED/EXAMINED BY THE MANUFACTURER'S SERVICE TECHNICIAN. THE TECHNICIAN FOUND NOTHING WRONG WITH ANY OF THE 3 STERILIZERS AND RECOMMENDED THAT THE BOWIE DICK TEST FROM A DIFFERENT LOT # BE RUN IN ALL 3 AUTOCLAVES. THIS WAS DONE AND ALL THREE PASSED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8443242 ↗
Other 3m Company products
- Steri-Drape11 models · 7 reports · 8 recalls
- 3M Attest5 models · 1 reports · 4 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
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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