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

Medline Surgical Kits with Codman Disposable Perforator recalled

Medline surgical kits containing Codman Disposable Perforators are being recalled because certain lots have inadequate welds that may cause the perforator to break or separate during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as Class I, which carries a mandatory minimum severity of 4 per the rubric. A device defect that could cause failure during neurosurgery—breakage or separation of a perforator—poses significant risk of serious injury.

Plain-English summary

Medline Industries, LP is recalling surgical kits that contain Codman Disposable Perforators due to inadequate welds on specific lots. The affected kits are: CRANI ADD A PACK (SKU DYNJ30926O), CRANIOTOMY (SKU CDS983611N), CRANIOTOMY CDS (SKU CDS983467J), CRANIOTOMY PACK (SKU DYNJ85807A and DYNJ85927), and MAJOR CRANIOTOMY PACK (SKU DYNJ82007A). A total of 1,853 units were distributed to hospitals and medical facilities in CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA, and WI.

Perforators with inadequate welds may break or separate during use. The specific lot numbers and UDI codes are detailed in the recall notice and should be checked before use.

Healthcare facilities that received these kits should stop using affected lots immediately and contact Medline or the FDA with questions about this recall.

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 — Surgical / Craniotomy Kits
Hazard
  • device-failure
  • weld-defect
  • product-breakage

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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