Henke-Ject-2 part luer sterile single use syringes — Class II medical device recall Z-2642-2023
Ongoing recall by Wolf, Henke Sass, Gmbh, reported 2023-10-04, distributed nationwide. Sterile barrier might be damaged compromising the sterility of the device.
| Recall number | Z-2642-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wolf, Henke Sass, Gmbh, Tuttlingen, N/A, Germany |
| Recall initiated | 2023-07-27 |
| Classified | 2023-09-27 |
| Reported by FDA | 2023-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 216,000 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04035873061991, 04035873062004 |
| Lot numbers | 22M28C8, 23A09C8 |
| Model numbers | 4100.000V0 |
Product
Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.000V0
Reason for recall
Sterile barrier might be damaged compromising the sterility of the device.
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-2642-2023. 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.