CLASS II ONGOING Device recall · Reported 10 May 2023 · FDA Enforcement Report
Lighting and Visualization Systems recalled by Steris
Steris is recalling Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical, distributed nationwide in the US. The recall was initiated on 17 Mar 2023 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-1475-2023
- FDA event ID
- 92040
- Recalling firm
- Steris, Mentor, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Mar 2023
- FDA classified
- 28 Apr 2023
- Reported
- 10 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 17 Mar 2023 | Recall initiated by company | |
| 28 Apr 2023 | Classified by FDA | +42 days |
| 10 May 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
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
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
Where it was distributed
Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
Questions about this recall
Is Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light recalled?
Yes. Steris recalled Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light on 17 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1475-2023.
Why was it recalled?
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
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
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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