The Recall Desk
Severity pendingFDA (Devices)·Z-2110-2025·Announced 2025-07-16

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'At

Pending LLM rewrite. Source: FDA_DEVICE Z-2110-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

The recalled product

Product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
Manufacturer
Alcon Research LLC
Category
Medical Device — Devices

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 (7)

  • ST JOHN'S 380655116074 14540-08 177H6V CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 178DYX CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 178FDJ CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 17AC44 CDN-CVS VIT 10K 25G+ HSC
  • ST JOHN'S 380655116074 14540-08 17AE5U CDN-CVS VIT 10K 25G+ HSC
  • W_O SLIT) KITANO HO 380655198353 17923-05 17CH88 J-CVS CAT PAK (W_IA
  • W_O SLIT) KITANO HO 380655199688 19037-05 17C991 J-COMB 25G20K (W_IA

Distribution

Distributed nationwide across the United States.

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