CLASS II ONGOING Device recall · Reported 9 Nov 2022 · FDA Enforcement Report
Bausch + Lomb Cataract Tray recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Bausch + Lomb Cataract Tray, distributed nationwide in the US. The recall was initiated on 30 Sep 2022 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-0160-2023
- FDA event ID
- 90946
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2022
- FDA classified
- 1 Nov 2022
- Reported
- 9 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 30 Sep 2022 | Recall initiated by company | |
| 1 Nov 2022 | Classified by FDA | +32 days |
| 9 Nov 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Where it was distributed
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Nationwide CaliforniaMinnesotaNorth CarolinaNew YorkOklahomaPennsylvaniaTennesseeTexas
Questions about this recall
Why was it recalled?
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Which lots are affected?
GTIN (01) 10889942339730, Lot Number 22DBM506
Where was it sold?
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 90946This product is part of a recall event; the main page for the event is Centurion Medical Products Nicu Picc Insertion Bundle W/o recalled.
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |