B — Class II medical device recall Z-2643-2023
Ongoing recall by B. Braun Medical, Inc., reported 2023-10-04, distributed nationwide. The sterile blister packaging may be damaged, and sterility may be compromised
| Recall number | Z-2643-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2023-08-07 |
| Classified | 2023-09-27 |
| Reported by FDA | 2023-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 534,000 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04046955597031 |
| Lot numbers | 22M28C8, 23A09C8 |
| Model numbers | NJ-4606108-02 |
Product
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
Reason for recall
The sterile blister packaging may be damaged, and sterility may be compromised
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-2643-2023. 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.