Regimen 28 Day — Class II medical device recall Z-1721-2019
Terminated recall by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, reported 2019-06-12, distributed in AZ, CA, CO, FL, GA, IL, KY, LA…. Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
| Recall number | Z-1721-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, Orange, CA, United States |
| Recall initiated | 2018-07-13 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2021-05-05 |
| Distributed | AZ, CA, CO, FL, GA, IL, KY, LA, MA, MN, MO, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA |
| Quantity | 31,904 |
| Lot numbers | 1038, 1038A, 1083, 1092B, 1121, 1193, 1250, 1262, 1274, 1324A, 1324B, 2037, 2122, 2142, 2219, 2306, 2337, 2347A, 3164 |
| Model numbers | 10-6465 |
Product
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Reason for recall
Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.
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-1721-2019. 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.