The Recall Desk
HighFDA (Devices)·Z-0627-2025·Announced 2024-12-11

Medline Medical Device Kits Recalled Due to Defective SafeAir Component

Medline is recalling 980 units of medical convenience kits manufactured using SafeAir Smoke Evacuation Pencil components that Stryker previously recalled. The kits 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: These are Class II medical device kits with no reported hospitalizations or injuries. However, they are risk-of-harm products used in surgical and biopsy procedures and contain components that were separately recalled, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 980 units of medical convenience kits manufactured using SafeAir Smoke Evacuation Pencil components. Stryker previously recalled the SafeAir Smoke Evacuation Pencil components used in these kits. The affected kits include breast biopsy packs, treatment room packs, and tamponade supplies.

These kits were distributed nationwide. Multiple product references and lot numbers are affected, as detailed in the FDA recall notice.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, RE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical/Biopsy Kits
Affected units
980

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 (20)

  • 1) REF DYNJ0160598C
  • UDI/DI 10195327304270 (each) 40195327304271 (case)
  • Lot Numbers: 23ADA376
  • 23DDA345
  • 23ADB824
  • 2) REF DYNJ0842590G
  • UDI/DI 10195327286439 (each) 40195327286430 (case)
  • Lot Numbers: 23HDA481
  • 23DDB914
  • 23DDA319
  • 3) REF DYNJ41473G
  • UDI/DI 10193489983982 (each) 40193489983983 (case)
  • Lot Numbers: 22KMD254
  • 23KBD038
  • 23EMK120
  • 23CMA828
  • 4) REF DYNJ41473I
  • UDI/DI 10195327584931 (each) 40195327584932 (case)
  • Lot Numbers: 24DBF911
  • 5) REF DYNJ44148G

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 28 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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