The Recall Desk
HighFDA (Devices)·Z-1095-2023·Announced 2023-02-15

Sterile Ophthalmic Procedure Trays Recalled for Packaging Integrity Risk

Medline Industries is recalling sterile ophthalmic procedure trays because blades in the kits can puncture the outer foil packaging, potentially compromising sterility. The recall affects 1,200 units distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of sterile surgical instruments where the potential hazard—packaging compromise leading to sterility breach—has not resulted in reported injuries or illnesses. It qualifies as a risk-of-harm product per the rubric, as use of non-sterile surgical instruments in ophthalmologic procedures could cause serious infection.

Plain-English summary

Medline Industries, LP is recalling specific sterile ophthalmic (eye) procedure trays due to a packaging defect. The sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging during handling or transport, which could compromise the sterility of the contents.

These recalled products include multiple tray types labeled as Basic Eye Pack-LF, Vitrectomy Pack-LF, Eye Pack-East-LF, and numerous other eye and oculoplastic surgical packs. The recall affects 260 cases (1,200 units) that were distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

Healthcare facilities that received these trays should stop using the affected lot numbers immediately and contact Medline Industries for return instructions. The specific lot numbers for each tray type are detailed in the official FDA recall notice. If any affected sterile trays were already used in procedures, healthcare providers should consult with infection control and their medical team regarding appropriate follow-up actions.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLO
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ophthalmic Surgical Trays
Hazard

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 (20)

  • a. BASIC EYE PACK-LF
  • Item Number: DYNJ0842521C
  • Case UDI/GTIN: 40193489352383
  • Unit UDI/GTIN: 10193489352382
  • Lot Number: 22JDA005
  • 22HDC265
  • b. VITRECTOMY PACK-LF
  • Item Number: DYNJ0843936F
  • Case UDI/GTIN: 40193489352390
  • Unit UDI/GTIN: 10193489352399
  • Lot Number: 22JDA822
  • 22IDB984
  • c. EYE PACK-EAST-LF
  • Item Number: DYNJ14064
  • Case UDI/GTIN: 40080196931102
  • Unit UDI/GTIN: 10080196931101
  • Lot Number: 22JBC143
  • 22IBF606
  • d. OSC OCULAR PLASTIC PACK-LF
  • Item Number: DYNJ31639B

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · puncture

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