FDA Medical Device Recalls (openFDA)
Johnson & Johnson Surgical Vision Inc: TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only
- Recall number
- Z-1033-2022
- Recalling firm
- Johnson & Johnson Surgical Vision Inc
- Product
- TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
- Status
- Open, Classified
- Initiated
- 2022-04-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential breach in the sterility barrier for tray ring covers.
- Root cause
- Under Investigation by firm
- Action
- On April 11, 2022, Johnson & Johnson Surgical Vision, Inc. (JJSV) issued an "Urgent Medical Device Recall" Notification to all affected consignees via UPS. In addition to informing consignees about the recalled device, JJSV asked consignees to take the following actions: 1. Identify if any of your inventory contains Johnson & Johnson Surgical Vision Tray Ring Covers with Part Number OM271000. 2. Immediately discontinue using and remove from your inventory all affected Tray Ring Covers (P/N: OM271000). Note that no other JJSV Tray Ring Covers are affected by this recall. 3. EVEN IF YOU HAVE NO INVENTORY, please complete the attached Customer Reply Form (on page 4). JJSV requires this information for reconciliation purposes with regulatory agencies. 4. If you have inventory of the Tray Ring Cover with part number OM271000, please complete the Customer Reply Form, noting the Lot numbers of the Tray Ring Covers, and contact Customer Support at 1-877-266-4543 Option 2 to obtain a RGA number and arrange the product return.
- Quantity
- not on file
- 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, Philippines, Taiwan.
- Lot, serial or model codes
- All Lots within Expiry: GTIN:05050474520707
- 510(k) numbers
- ["K951462"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 3003843509
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28