Brand Name: Carefree Surgical Specialties Product Name:… — Class II medical device recall Z-2281-2025
Ongoing recall by Carefree Surgical Specialties, reported 2025-08-20, distributed nationwide. Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. In
| Recall number | Z-2281-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefree Surgical Specialties, Nampa, ID, United States |
| Recall initiated | 2025-07-01 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 20 |
| Reason classes | foreign material, sterility |
| Lot numbers | 1595 |
| Model numbers | 15508/25 |
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Reason for recall
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
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-2281-2025. 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.