CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
Gyn Laparoscopy Pack recalled by AVID Medical
Avid Medical is recalling Gyn Laparoscopy Pack, distributed in 7 states. The recall was initiated on 11 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2250-2025
- FDA event ID
- 97149
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2025
- FDA classified
- 4 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 11 Jun 2025 | Recall initiated by company | |
| 4 Aug 2025 | Classified by FDA | +54 days |
| 13 Aug 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Product as listed by the FDA
GYN LAPAROSCOPY PACK. Medical convenience kit.
Where it was distributed
Domestic: CA, IL, MD, OH, PA, TX, WA.
Questions about this recall
Why was it recalled?
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Which lots are affected?
Model No. NAFB055-08, NAMC436-11, VMCC030-06; UDI: 10809160405185, 10809160417621, 10809160415245, 10809160419021; Kit Lot No. 1595523, 1598524, 1598523, 1628236, 1634348, 1636865, 1645025, 1645227, 1608234, 1608349, 1608466, 1613607, 1613139, 1613608, 1616927, 1622475, 1628656, 1632993, 1596145, 1603597, 1608059, 1619856.
Where was it sold?
Domestic: CA, IL, MD, OH, PA, TX, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 97149This product is part of a recall event; the main page for the event is Gyn Robotic Pack recalled by AVID Medical.
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