a — Class III medical device recall Z-1793-2022
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-10-05, distributed nationwide. Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperature
| Recall number | Z-1793-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2022-05-25 |
| Classified | 2022-09-26 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Reason classes | temperature control |
| UPC / GTIN / UDI-DI | 00724995002558, 00724995023867, 00724995084653, 00724995154233, 00724995161552, 00724995161569, 10724995023864, 10724995084650, 10724995154230, 10724995161559, 10724995161566 |
| Model numbers | LCB035, LCB044, LCB049, LCB053, PCC006, S3069 |
Product
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biological Indicator Pack Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vial Vaporized Hydrogen Peroxide Model Number:LCB044. e. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB049. f. STERIS CORP VERIFY Sterilization Indicator Challenge Pack Steam Catalog #LCB035.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1793-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.