CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
Henry Schein, Universal Tray recalled by Stradis Medical
Stradis Medical is recalling Henry Schein, Universal Tray, distributed nationwide in the US. The recall was initiated on 2 Nov 2022 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-0517-2023
- FDA event ID
- 91124
- Recalling firm
- Stradis Medical, Peachtree Corners, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Nov 2022
- FDA classified
- 14 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2022 | Recall initiated by company | |
| 14 Dec 2022 | Classified by FDA | +42 days |
| 21 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
Where it was distributed
US nationwide distribution, and Canada.
Questions about this recall
Is Henry Schein, Universal Tray recalled?
Yes. Stradis Medical recalled Henry Schein, Universal Tray on 2 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0517-2023.
Why was it recalled?
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Which lots are affected?
UDI/DI (case) H65857027871, UDI/DI (kit)M75257027870, Serial/Lot Numbers: 22262491981
Where was it sold?
US nationwide distribution, and Canada.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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