The Recall Desk
HighFDA (Devices)·Z-0159-2023·Announced 2022-11-09

Surgical eye kits recalled for breached sterile pouches

Medline Industries recalls Bausch + Lomb eye muscle surgical kits due to breached breather pouches that may compromise sterility. The affected kits (Lot 22DBN366) were distributed nationwide.

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: FDA Class II recall affecting sterile surgical kits with breached seal pouches, presenting a risk of compromised sterility in surgical procedures. No adverse events or injuries have been reported in the source text.

Plain-English summary

Medline Industries is recalling Bausch + Lomb eye muscle surgical kits (Reference VAL036EMESB, Lot 22DBN366) after receiving complaints of defective breather pouches.

Some breather pouches in the affected sterile surgical kits show openings in their seals. Breached seals compromise the sterility assurance of the kit contents, which is critical for safe surgical use.

The recall involves 16 kits distributed nationwide to healthcare facilities in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.

The recalled product

Product
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kit / Eye Surgery
Hazard
  • seal-breach
  • sterility-risk

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 (2)

  • GTIN (010 10889942352920
  • Lot Number 22DBN366

Distribution

Distributed nationwide across the United States.

Related recalls

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