The Recall Desk
HighFDA (Devices)·Z-1077-2023·Announced 2023-02-15

Sterile Surgical Trays Recalled for Blade Puncture of Packaging

Medline Industries is recalling sterile surgical trays used in plastic and reconstructive surgery because blades within the kits can puncture the outer foil packaging, potentially compromising sterility. Approximately 15,009 units were distributed nationwide and internationally.

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 risk-of-harm product where sterile packaging can be compromised through blade puncture, potentially leading to contamination during surgical use. No illnesses or injuries have been reported; the hazard is theoretical based on the product defect.

Plain-English summary

Medline Industries, LP is recalling sterile procedural surgical trays used in plastic and reconstructive surgery procedures. The affected products include sterile kits containing surgical instruments and supplies in various configurations, with approximately 6,420 cases (15,009 units) involved in the recall.

The sterile blades contained within these surgical kits have the potential to puncture the outer foil layer of the sterile packaging. When the packaging is punctured, the sterile contents may become exposed to environmental contamination, compromising the sterility of the surgical instruments.

The recalled trays were distributed worldwide, including throughout the United States and internationally to Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Healthcare facilities, surgical centers, and hospitals using these sterile trays may be affected.

Healthcare providers should immediately discontinue use of recalled sterile trays and contact Medline Industries for replacement or return instructions. Facility personnel should verify that trays with the affected lot numbers are removed from inventory before use in any procedures. The FDA has classified this as a Class II recall.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays / Plastic Surgery
Hazard

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. BREAST AUGMENTATION
  • Item Number: CDS982254L
  • Case UDI/GTIN: 40195327084791
  • Unit UDI/GTIN: 10195327084790
  • Lot Number: 22JBU069
  • 22IBN271
  • b. BREAST REDUCTION CDS
  • Item Number: CDS982255I
  • Case UDI/GTIN: 40195327084807
  • Unit UDI/GTIN: 10195327084806
  • Lot Number: 22JBB306
  • c. CUH ABDOMINOPLASTY CDS
  • Item Number: CDS983176I
  • Case UDI/GTIN: 40193489767477
  • Unit UDI/GTIN: 10193489767476
  • Lot Number: 22JBJ560
  • 22JBD705
  • d. ACH PLASTICS BREAST-LF
  • Item Number: CDS983639J
  • Case UDI/GTIN: 40195327228140

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 →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · blade puncture

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