3M Company
3M Company appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 335 510(k) clearances, 40 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2231-2025, Class II) was initiated on April 22, 2025. Its most recent 510(k) clearance was granted on January 28, 2025.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 335
- Inspections
- 40
- Compliance Actions
- 1
Known Names
3m deutschland, 3m unitek corporation, 3m company
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2231-2025 | Class II | 3M Ranger Irrigation Fluid Warming Set, REF 24750 | April 22, 2025 |
| Z-2483-2025 | Class I | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 | April 10, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader | January 28, 2025 |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Cle | November 25, 2024 |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Att | October 18, 2024 |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest | September 12, 2024 |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | June 27, 2024 |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri- | June 27, 2024 |
| DEN230068 | 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBow | May 21, 2024 |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto | March 15, 2024 |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | May 18, 2023 |
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Mediu | March 23, 2023 |
| K223263 | Prevena Plus 125 Therapy Unit | February 13, 2023 |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | November 1, 2022 |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228 | September 23, 2022 |
| K220560 | Dermatac Drape | July 14, 2022 |
| K211705 | 3M Attest Rapid Readout Biological Indicator, 1295 | June 28, 2022 |
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) | June 24, 2022 |
| K220507 | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large | May 23, 2022 |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 | May 23, 2022 |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | April 20, 2022 |
| K213809 | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M At | April 6, 2022 |