The Recall Desk
HighFDA (Devices)·Z-1811-2025·Announced 2025-06-11

[pending] Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59

Pending LLM rewrite. Source: FDA_DEVICE Z-1811-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

The recalled product

Product
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYN
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
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 (5)

  • 1. CRANI ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea)
  • 40195327645091 (case) Lots 24DBS813 SKU DYNJ904168F UDI-DI 10195327395728 (ea)
  • 40195327395729 (case) Lots 24DBU188 SKU DYNJ908404B UDI-DI 10195327410506 (ea)
  • 40195327574056 (case) Lots 24CBF778 SKU DYNJ09882I UDI-DI 10198459058172 (ea)
  • 40195327201570 (case) Lots 23JBK426 SKU DYNJ903713L UDI-DI 10195327531218 (ea)

Distribution

Distributed in 13 states:

  • CA
  • FL
  • IL
  • IN
  • KY
  • MA
  • MD
  • MN
  • NY
  • TX
  • VT
  • WA
  • WI

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