CLASS II ONGOING Device recall · Reported 11 May 2022 · FDA Enforcement Report

Tray Ring Cover recalled by Johnson & Johnson Surgical

Johnson & Johnson Surgical Vision is recalling Tray Ring Cover, distributed nationwide in the US. The recall was initiated on 6 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots within Expiry: GTIN:05050474520707

Quantity recalledN/A

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-1033-2022
FDA event ID: 89991
Recalling firm: Johnson & Johnson Surgical Vision, Santa Ana, CA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Apr 2022
FDA classified: 4 May 2022
Reported: 11 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

6 Apr 2022	Recall initiated by company
4 May 2022	Classified by FDA	+28 days
11 May 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

Potential breach in the sterility barrier for tray ring covers.

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

TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

Where it was distributed

Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.

Nationwide Alabama Arkansas Arizona California Florida Georgia Hawaii Illinois Indiana Kansas Massachusetts Maryland Minnesota Missouri North Carolina Nebraska New Jersey New Mexico Nevada New York

Questions about this recall

Is Tray Ring Cover recalled?

Yes. Johnson & Johnson Surgical Vision recalled Tray Ring Cover on 6 Apr 2022. The recall is Class II and its status is Ongoing. Recall number Z-1033-2022.

Why was it recalled?

Potential breach in the sterility barrier for tray ring covers.

Which lots are affected?

All Lots within Expiry: GTIN:05050474520707

Where was it sold?

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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