The Recall Desk
HighFDA (Devices)·Z-0628-2025·Announced 2024-12-11

MEDLINE dental and oral surgery kits recalled due to defective component

MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.

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: This is a Class II FDA recall of surgical and dental convenience kits containing a component previously recalled by another manufacturer. Although no illnesses or injuries have been reported, these medical devices are used in invasive procedures and qualify as risk-of-harm products.

Plain-English summary

MEDLINE INDUSTRIES, LP is recalling four types of dental and oral surgery convenience kits distributed nationwide. The affected products are ORAL SURGERY PK RFID (REF DYNJ52404I), ORL PACK (REF DYNJ59073B), ORAL MAXILOFACIAL PK (REF DYNJ80226A), and DENTAL MINOR PACK (REF DYNJ83140), totaling 944 units.

These kits were manufactured using SafeAir Smoke Evacuation Pencils, certain lots of which were previously recalled by Stryker. The pencil component contains a defect that prompted the original manufacturer's recall, necessitating this recall of the MEDLINE kits containing the affected lots.

The specific lot numbers for each kit type are available in the FDA recall notice (Z-0628-2025) and from MEDLINE. Healthcare facilities and dental practices should verify their inventory to identify if they have received any affected units.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Dental Kits
Hazard
Affected units
944

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 DYNJ52404I
  • UDI/DI 10195327339159 (each) 40195327339150 (case)
  • Lot Numbers: 23HDB384
  • 23IDC338
  • 2) REF DYNJ59073B
  • UDI/DI 10195327200398 (each) 40195327200399 (case)
  • Lot Numbers: 23CBG401
  • 22JBI913
  • 23GBU324
  • 23EBL522
  • 23BBA464
  • 23CBU743
  • 23IBS781
  • 3) REF DYNJ80226A
  • UDI/DI 10195327195021 (each) 40195327195022 (case)
  • Lot Numbers: 22GBV225
  • 22FBV173
  • 22FBV174
  • 4) REF DYNJ83140
  • UDI/DI 10195327232955 (each) 40195327232956 (case)

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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Same hazard · component defect

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