The Recall Desk
ModerateFDA (Devices)·Z-0709-2023·Announced 2022-12-21

DeRoyal GEO-MED Cataract Pack Recalled Across Multiple US States

DeRoyal Industries is voluntarily recalling 834 GEO-MED Cataract Pack kits (REF 89-5790.08) distributed across 23 US states. The FDA classified this as a Class II recall, though the specific reason has not been disclosed.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary manufacturer-initiated recall with no reported illnesses or injuries. The FDA Class II classification without reported hospitalizations, combined with the voluntary nature of the recall, indicates a moderate-severity issue consistent with precautionary recalls.

Plain-English summary

DeRoyal Industries Inc is voluntarily recalling the GEO-MED CATARACT PACK, REF 89-5790.08. The recall affects 834 kits that were distributed to healthcare facilities across 23 US states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

The FDA classified this as a Class II recall on December 15, 2022, following the firm's initiation of the recall on November 3, 2022. The specific reason for the recall is not detailed in the available recall notice.

The affected lot numbers and expiration dates are: 55966890 (02/01/2023), 56020131 (03/01/2023), 56184435 (02/01/2023), 56618387 (06/01/2023), 57001493 (06/01/2023), 57227821 (09/01/2023), 57466709 (09/01/2023), 57589522 (09/01/2023), 57749750 (12/01/2023), and 5786389 (12/01/2023). Healthcare facilities that received these lots should contact DeRoyal Industries for guidance.

The recalled product

Product
GEO-MED CATARACT PACK, REF 89-5790.08
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Ophthalmic Surgical Pack

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot Numbers: 55966890 exp 02/01/2023
  • 56020131 exp 03/01/2023
  • 56184435 exp 02/01/2023
  • 56618387 exp 06/01/2023
  • 57001493 exp 06/01/2023
  • 57227821 exp 09/01/2023
  • 57466709 exp 09/01/2023
  • 57589522 exp 09/01/2023
  • 57749750 exp 12/01/2023
  • 5786389 ezp 12/01/2023

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category