a — Class III medical device recall Z-1805-2022
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-1805-2022 |
|---|---|
| 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 | 00612479193710, 00612479193727, 00612479193734, 00612479193741, 00612479193758, 00612479193765, 00612479193772, 00612479193789, 00612479193796, 00612479193802, 00612479193819, 00612479193826, 00612479193833, 00612479193840, 00612479193857, 00612479193864, 00612479193871, 00612479193888, 00612479193895, 00612479193901, 00612479193918, 00612479193925, 00612479193932, 00612479193949 |
| Model numbers | 16-10144R, 3557, 3558, 3559, 3560, 3561, 3562, 3563, 3564 |
Product
a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X4.75" (10/BX) Catalog #3558. d. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X8" (5/BX 10 Catalog #3559. e. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3560. f. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 2"X2" (10/BX 10BX/C Catalog #3561. g. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X4.75" (10/BX 1 Catalog #3562. h. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS) Catalog #3563. i. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE ROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3564. j. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, SKIN FOLD MGMNT AG 10"X144" (1/BX 12BX/CS) Catalog #16-10144R
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
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-1805-2022. 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.