Pulsator Arterial Blood Sampling Kit — Class II medical device recall Z-1100-2026
Ongoing recall by ICU Medical Inc., reported 2026-01-21, distributed nationwide. Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood
| Recall number | Z-1100-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc., Minneapolis, MN, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-01-15 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 64,290 total |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 30351688006176, 30351688029540, 30351688039150, 30351688073062, 30351688081173 |
| Lot numbers | 4080P-2, 4080PG, 4084P-1, 6131838, 6131839, 6141992, 6141999, 6142000, 6142001, 6142002, 6147906, 6147907, 6156228 |
| Model numbers | 4044EG-1, 4080P-2, 4080PE, 4080PG, 4084P-1 |
Product
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Reason for recall
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
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-1100-2026. 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.