Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm
FDA device recall Z-1320-2026 · posted 2026-02-06 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- Reason for recall
- These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
- Action taken
- On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NLH
- Quantity affected
- 311
- Distribution
- Distribution US nationwide.
- Date initiated
- 2025-12-22
- Date posted
- 2026-02-06
- Location
- Northfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (K242225) | Surgical Instrument Service and Savings, Inc. | 2024-11-29 |