Recall Z-2251-2025
AVID Medical, Inc. · initiated June 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GYN ROBOTIC PACK. Medical convenience kit.
Codes / lots: Model No. NAMC474-01; UDI: 10809160375044; Kit Lot No. 1620573, 1620572, 1621883, 1621884, 1628673.
Reason for recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
FDA-determined cause: Under Investigation by firm
Action taken
Consignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to complaints@owens-minor.com
Details
- Recall number
- Z-2251-2025
- Initiated
- June 11, 2025
- Posted by FDA
- August 4, 2025
- Product code
- OKV – Obstetrical Kit
- Quantity
- 45 units
- Distribution
- Domestic: CA, IL, MD, OH, PA, TX, WA.
- Recalling firm
- AVID Medical, Inc., Toano, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2240-2025 Class II | LAPAROSCOPIC TRAY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2241-2025 Class II | CARDIAC ROBOT PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2242-2025 Class II | CT DAVINCI. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2243-2025 Class II | DA VINCI PACK URO/PROSTATE. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2244-2025 Class II | DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2245-2025 Class II | DAVINCI UROLOGY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2246-2025 Class II | GEN LAPAROSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2247-2025 Class II | GENERAL LAPAROSCOPY TRAY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2248-2025 Class II | GENERAL ROBOTIC PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2249-2025 Class II | GS ENDOSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2250-2025 Class II | GYN LAPAROSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2252-2025 Class II | HVI CARDIAC ROBOT PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2253-2025 Class II | LAP CHOLE PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2254-2025 Class II | LAPAROSCOPIC GYN. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2255-2025 Class II | LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2256-2025 Class II | LAPAROSCOPY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2257-2025 Class II | LAVH PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2258-2025 Class II | MAJOR THORACOSCOPY BASIN. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2259-2025 Class II | PACK GENERAL ROBOTIC. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2260-2025 Class II | PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2261-2025 Class II | PARTIAL NEPHRECTOMY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2262-2025 Class II | ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |
| Z-2263-2025 Class II | ROBOTIC URO/GYN PACK. Medical convenience kit.CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | 06/11/2025Open, Classified |