The Recall Desk
HighFDA (Devices)·Z-1809-2025·Announced 2025-06-11

[pending] Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O

Pending LLM rewrite. Source: FDA_DEVICE Z-1809-2025.

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 ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
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 (17)

  • 1. CRANI ADD A PACK
  • SKU DYNJ30926O
  • UDI-DI 10195327539153 (EA)
  • 40195327539154 (CASE) KIT LOTS 24AMF811 2. CRANIOTOMY
  • SKU CDS983611N
  • UDI-DI 10195327466626 (EA)
  • 40195327466627 (CASE) KIT LOTS 23KBA720 23LBI611 23LBJ586 3. CRANIOTOMY CDS
  • SKU CDS983467J
  • UDI-DI 10195327561116 (EA)
  • SKU DYNJ85807A
  • UDI-DI 10195327637392 (EA)
  • 40195327637393 (CASE) KIT LOTS 24CBB843 24EBC889 24GBY029
  • SKU DYNJ85927
  • UDI-DI 10195327575571 (EA)
  • 40195327575572 (CASE) KIT LOTS 24BMD310 24EMI836 5. MAJOR CRANIOTOMY PACK
  • SKU DYNJ82007A UDI-DI 10195327635466 (EA)
  • 40195327635467 (CASE) KIT LOTS 24CMA496 24HMI081 24HMI978

Distribution

Distributed in 13 states:

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

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