Z-1475-2023Class II

Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers...

Name: Z-1475-2023 Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers...
Creator: Steris Corporation
Published: 2023-03-17
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2023-03-17 / Open, Classified / root cause: sterility

FDA source

Steris Corporation began a recall of Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers... on 2023-03-17. FDA classified it as Class II and gives the reason as "Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1475-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-17
Posted: 2023-04-28
Recalling firm: STERIS Corporation
Product: Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
Product code: FTA Light, Surgical, Accessories
Reason for recall: Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Steris issued Urgent Medical Device Recall Letter on 3/17/23 via FedEx. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. For the full list of lots affected by this recall, please reference Attachment A to this letter. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. If product was transferred to any other entities within your organization, please forward this recall notice accordingly. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: [email protected] or via fax to (440) 392-8963. Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. If you have questions regarding this recall, please contact STERIS Customer Service at 1-800-548-4873, or email the RMA Team at [email protected].
Quantity in commerce: 1,358,520 covers
Distribution: Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
Product codes and lots: GTIN number: 00724995150136 Lot Numbers: 9604187 / 9604187A 9604188 / 9604188A 9604189 / 9604189A 9604190 / 9604190A 9604191 / 9604191A 9799082 / 9799082A 9799083 / 9799083A 9799084 / 9799084A 9799085 / 9799085A 9799086 / 9799086A 9799087 / 9799087A 9799088 / 9799088A 9799089 / 9799089A 9799090 / 9799090A 9799091 / 9799091A 9799092 / 9799092A 9799093 / 9799093A 9799094 / 9799094A 9799095 / 9799095A 9799096 / 9799096A 9799097 / 9799097A 9799098 / 9799098A 9799099 / 9799099A 9799100 / 9799100A 9799101 / 9799101A 9799102 / 9799102A 9799103 / 9799103A 9799104 / 9799104A 9799105 / 9799105A 9799106 / 9799106A 9799107 / 9799107A 9799108 / 9799108A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1475-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1475-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-04-28
Z-1476-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-10	2023-04-28

Product code FTA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)