Class II — Wolf, Henke Sass, Gmbh
| Recalling firm | HENKE-SASS WOLF, GMBH. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Sterile barrier might be damaged compromising the sterility of the device. |
| 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 |
| Quantity | 216,000 |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Initiated | 2023-07-27 |
| Classified | 2023-09-27 |
| Recall number | Z-2642-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Wolf, Henke Sass, Gmbh (Z-2642-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92836/
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