3M Company

FDA Regulatory Profile

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
335
Inspections
42
Compliance Actions
1

Known Names

3m unitek corporation, 3m deutschland, 3m company

Recent Recalls

NumberClassProductDate
Z-2231-2025Class II3M Ranger Irrigation Fluid Warming Set, REF 24750April 22, 2025
Z-2483-2025Class I3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370April 10, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-readerJanuary 28, 2025
K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity CleNovember 25, 2024
K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ AttOctober 18, 2024
K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™September 12, 2024
K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-June 27, 2024
K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)June 27, 2024
DEN2300683M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowMay 21, 2024
K2338143M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ AutoMarch 15, 2024
K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)May 18, 2023
K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, MediuMarch 23, 2023
K223263Prevena Plus 125 Therapy UnitFebruary 13, 2023
K2225083M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248November 1, 2022
K2221523M™ Attest™ Hydrogen Peroxide Indicator Tape 1228September 23, 2022
K220560Dermatac DrapeJuly 14, 2022
K2117053M Attest Rapid Readout Biological Indicator, 1295June 28, 2022
K2209423M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)June 24, 2022
K2205643M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355May 23, 2022
K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, LargeMay 23, 2022
K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EApril 20, 2022
K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M AtApril 6, 2022