Device recall: LAPAROSCOPIC TRAY. Medical convenience kit.
Class II FDA enforcement event 97149. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
AVID Medical, Inc. started this device recall on 11 Jun 2025. The firm address in the FDA record is in Toano, VA. FDA put the recall in Class II. FDA event 97149 has 24 product records. The first FDA enforcement report date is 13 Aug 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Domestic: CA, IL, MD, OH, PA, TX, WA.
Recalling firm
AVID Medical, Inc., Toano, VA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
24 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2240-2025 | LAPAROSCOPIC TRAY. Medical convenience kit. | 40 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2241-2025 | CARDIAC ROBOT PACK. Medical convenience kit. | 20 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2242-2025 | CT DAVINCI. Medical convenience kit. | 12 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2243-2025 | DA VINCI PACK URO/PROSTATE. Medical convenience kit. | 21 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2244-2025 | DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit. | 626 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2245-2025 | DAVINCI UROLOGY. Medical convenience kit. | 166 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2246-2025 | GEN LAPAROSCOPY PACK. Medical convenience kit. | 321 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2247-2025 | GENERAL LAPAROSCOPY TRAY. Medical convenience kit. | 574 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2248-2025 | GENERAL ROBOTIC PACK. Medical convenience kit. | 203 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2249-2025 | GS ENDOSCOPY PACK. Medical convenience kit. | 816 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2250-2025 | GYN LAPAROSCOPY PACK. Medical convenience kit. | 346 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2251-2025 | GYN ROBOTIC PACK. Medical convenience kit. | 45 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2252-2025 | HVI CARDIAC ROBOT PACK. Medical convenience kit. | 20 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2253-2025 | LAP CHOLE PACK. Medical convenience kit. | 85 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2254-2025 | LAPAROSCOPIC GYN. Medical convenience kit. | 18 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2255-2025 | LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit. | 30 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2256-2025 | LAPAROSCOPY PACK. Medical convenience kit. | 452 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2257-2025 | LAVH PACK. Medical convenience kit. | 292 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2258-2025 | MAJOR THORACOSCOPY BASIN. Medical convenience kit. | 128 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2259-2025 | PACK GENERAL ROBOTIC. Medical convenience kit. | 656 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2260-2025 | PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit. | 46 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2261-2025 | PARTIAL NEPHRECTOMY PACK. Medical convenience kit. | 52 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2262-2025 | ROBOTIC PROSTATECTOMY PACK. Medical convenience kit. | 24 units | Class II | Ongoing | 13 Aug 2025 |
| Z-2263-2025 | ROBOTIC URO/GYN PACK. Medical convenience kit. | 372 units | Class II | Ongoing | 13 Aug 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 24Median of the firm: 3
- Events of the firm on the register
- 24
Other events of the firm
Official channels
- FDA enforcement report Z-2240-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 97149. https://recallregister.com/fda/ii/97149/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Domestic: CA, IL, MD, OH, PA, TX, WA.
- What quantity of product is in FDA event 97149?
- The event has 24 product records. The first record gives this quantity:
40 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.