High FDA (Devices)·Z-1070-2023·Announced 2023-02-15

Sterile Procedural Trays recalled for potential blade puncture of packaging

Medline Industries is recalling five types of sterile procedural trays because sterile blades inside can puncture the outer foil packaging, potentially compromising sterility and creating contamination risk.

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 an FDA Class II recall with no reported illnesses or injuries. The hazard represents a risk of harm—compromised sterility in surgical equipment could lead to contamination—and meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP is recalling five types of sterile procedural trays used in oral surgery and dental procedures: Oral Surgery Pack-LF, Extraction Pack, Oral Surgery Pack, Dental Minor Pack, and Oral. The recall was initiated because the sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging.

The affected trays have been distributed worldwide, with distribution to the United States and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. A total of 174 cases containing 750 units are subject to this recall. Healthcare facilities and dental offices that received these products may have affected inventory.

The FDA classified this as a Class II recall. Further information is available from the FDA and Medline Industries, including specific lot numbers for each product type affected by this recall.

The recalled product

Product: Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical / Dental Procedural
Hazard: puncture
sterility-compromise

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)

a. ORAL SURGERY PACK-LF
Item Number: DYNJ20491N
Case UDI/GTIN: 40195327024582
Unit UDI/GTIN: 10195327024581
Lot Number: 22IDA002
b. EXTRACTION PACK
Item Number: DYNJ49329F
Case UDI/GTIN: 40195327059638
Unit UDI/GTIN: 10195327059637
Lot Number: 22HBR730
c. ORAL SURGERY PACK
Item Number: DYNJ52404G
Case UDI/GTIN: 40195327222612
Unit UDI/GTIN: 10195327222611
Lot Number: 22IDA539
22HDB737
d. DENTAL MINOR PACK
Item Number: DYNJ83140
Case UDI/GTIN: 40195327232956
Unit UDI/GTIN: 10195327232955

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 38 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 38 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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