FDA Device recall Z-2254-2024
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, 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 with Wire Speculum, REF 18069W, 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-2254-2024 |
| 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 with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Reason
Sterilization certificates could not be validated by the supplier
Identifiers
| code_info | UDI/DI 20841305107612, Lot Number P62764970R |
|---|
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-2254-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.