FDA Device recall Z-2251-2024
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
- FDA Device
- Class I
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class I recall of BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye) by Synergetics, citing sterilization certificates could not be validated by the supplier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2251-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-06-12 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Synergetics |
| Distribution | US |
Product
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Reason
Sterilization certificates could not be validated by the supplier
Identifiers
| code_info | UDI/DI 20841305107544, Lot Number P62764979R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2251-2024%22
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