Recall Register

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.

FDA event 97149: product records
Recall numberProductQuantityClassStatusReport date
Z-2240-2025LAPAROSCOPIC TRAY. Medical convenience kit.40 unitsClass IIOngoing13 Aug 2025
Z-2241-2025CARDIAC ROBOT PACK. Medical convenience kit.20 unitsClass IIOngoing13 Aug 2025
Z-2242-2025CT DAVINCI. Medical convenience kit.12 unitsClass IIOngoing13 Aug 2025
Z-2243-2025DA VINCI PACK URO/PROSTATE. Medical convenience kit.21 unitsClass IIOngoing13 Aug 2025
Z-2244-2025DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.626 unitsClass IIOngoing13 Aug 2025
Z-2245-2025DAVINCI UROLOGY. Medical convenience kit.166 unitsClass IIOngoing13 Aug 2025
Z-2246-2025GEN LAPAROSCOPY PACK. Medical convenience kit.321 unitsClass IIOngoing13 Aug 2025
Z-2247-2025GENERAL LAPAROSCOPY TRAY. Medical convenience kit.574 unitsClass IIOngoing13 Aug 2025
Z-2248-2025GENERAL ROBOTIC PACK. Medical convenience kit.203 unitsClass IIOngoing13 Aug 2025
Z-2249-2025GS ENDOSCOPY PACK. Medical convenience kit.816 unitsClass IIOngoing13 Aug 2025
Z-2250-2025GYN LAPAROSCOPY PACK. Medical convenience kit.346 unitsClass IIOngoing13 Aug 2025
Z-2251-2025GYN ROBOTIC PACK. Medical convenience kit.45 unitsClass IIOngoing13 Aug 2025
Z-2252-2025HVI CARDIAC ROBOT PACK. Medical convenience kit.20 unitsClass IIOngoing13 Aug 2025
Z-2253-2025LAP CHOLE PACK. Medical convenience kit.85 unitsClass IIOngoing13 Aug 2025
Z-2254-2025LAPAROSCOPIC GYN. Medical convenience kit.18 unitsClass IIOngoing13 Aug 2025
Z-2255-2025LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.30 unitsClass IIOngoing13 Aug 2025
Z-2256-2025LAPAROSCOPY PACK. Medical convenience kit.452 unitsClass IIOngoing13 Aug 2025
Z-2257-2025LAVH PACK. Medical convenience kit.292 unitsClass IIOngoing13 Aug 2025
Z-2258-2025MAJOR THORACOSCOPY BASIN. Medical convenience kit.128 unitsClass IIOngoing13 Aug 2025
Z-2259-2025PACK GENERAL ROBOTIC. Medical convenience kit.656 unitsClass IIOngoing13 Aug 2025
Z-2260-2025PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.46 unitsClass IIOngoing13 Aug 2025
Z-2261-2025PARTIAL NEPHRECTOMY PACK. Medical convenience kit.52 unitsClass IIOngoing13 Aug 2025
Z-2262-2025ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.24 unitsClass IIOngoing13 Aug 2025
Z-2263-2025ROBOTIC URO/GYN PACK. Medical convenience kit.372 unitsClass IIOngoing13 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

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.