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Unrated Medical device recall · FDA · Published April 6, 2022

Johnson & Johnson Surgical Vision Tray Ring Covers May Breach Sterility Barrier

Johnson & Johnson Surgical Vision recalls sterile tray ring covers (OM27100:1) due to potential sterility barrier breach. Affected items contain a specific lot number range. Consumers should check their product details.

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Recalling firmJohnson & Johnson Surgical Vision Inc1700 E Saint Andrew Pl · Santa Ana, CA 92705-4933
✎ GovInfoNow plain-language explainer

Johnson & Johnson Surgical Vision is recalling sterile tray ring covers (model OM271000) because they may have a sterility barrier that could be breached. This could lead to contamination of surgical instruments during procedures, posing a risk to patient safety. Read more at govinfonow.com/recall/60836-johnson-johnson-surgical-vision-tray-ring-covers-may-breach-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/60836-johnson-johnson-surgical-vision-tray-ring-covers-may-breach-sterility · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1033-2022

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“Johnson & Johnson Surgical Vision Tray Ring Covers May Breach Sterility Barrier.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60836-johnson-johnson-surgical-vision-tray-ring-covers-may-breach-sterility. Based on FDA recall #Z-1033-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1033-2022%22&limit=1).

Johnson & Johnson Surgical Vision Inc recalled TRAY RING COVER REF OM271000 due to a potential breach in the sterility barrier, according to the FDA on April 6, 2022.

How to tell if you have it

  • Brand: Johnson & Johnson Surgical Vision
  • Product: TRAY RING COVER, REF OM271000
  • UPC: 05050474520707
  • Lot codes: All Lots within Expiry

The hazard

The recall addresses a potential breach in the sterility barrier for tray ring covers.

Context

GovInfoNow's records show Johnson & Johnson Surgical Vision, Inc. has 14 other recalls on record since May 9, 2018. Other recent recalls of similar products include HEALON Products for Corneal Injury Risk (July 31, 2026), Irrigation Sleecks: Risk of Insufficient Flow During Eye Surgery (March 14, 2024), and TECNIS Toric II IOLs with Angle Issue (Dec. 12, 2023). Other recent recalls of similar products include Intuitive Surgical Ion Vision Probe Bag Recall (Dec. 4, 2025), Medline Convenience Kits May Contaminate Patient Due to Open Seals (July 31, 2026), and Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (Jan. 7, 2026).

How to tell if you have this one

Check for the model number OM271000 on the product. The product contains one sterile tray ring cover and is sold with a prescription (Rx Only). The lot numbers are within the expiry range indicated by the GTIN:05050474520707.

  • Brand
    Johnson & Johnson Surgical Vision
  • Product
    Johnson & Johnson Surgical Vision Inc recalls TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the model number OM271000 and the lot number range indicated by GTIN:05050474520707.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 27 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Maryland, Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Apr 6, 202212. FDA classified it Class II: May 4, 202223. Published in FDA’s Enforcement Report: May 11, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1033-2022 (April 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1033-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA