The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1092-2023·Announced 2023-02-15

Sterile Procedural Trays With Blades That May Puncture Packaging

Medline recalls sterile surgical trays because internal blades can puncture the outer protective foil packaging, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: No illnesses or injuries have been reported. Although sterile surgical instruments are high-risk products, the hazard is described as potential rather than confirmed, and the recall is Class II rather than Class I.

Plain-English summary

Medline Industries is recalling sterile procedural trays, primarily used for cesarean section and orthopedic surgery. The recall affects 11,886 cases containing approximately 27,144 units with worldwide distribution including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates.

The hazard involves sterile blades within the trays that have the potential to puncture the outer foil protective layer of the sterile packaging. A punctured foil layer would compromise the sterility of the entire surgical kit and its instruments, potentially introducing contamination in the surgical field.

Specific product lot numbers, item numbers, and case/unit identification codes (UDI/GTIN) are available in the FDA recall database for verification against inventory held by healthcare facilities.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l.…
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Trays
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. C-SECTION OR 30 CDS
  • Item Number: CDS820075W
  • Case UDI/GTIN: 40195327209798
  • Unit UDI/GTIN: 10195327209797
  • Lot Number: 22JBX603
  • 22JBX483
  • b. C-SECTION CDS
  • Item Number: CDS830218J
  • Case UDI/GTIN: 40888277530172
  • Unit UDI/GTIN: 10888277530171
  • Lot Number: 22JBV584
  • c. C-SECTION CDS
  • Item Number: CDS980747J
  • Case UDI/GTIN: 40193489923613
  • Unit UDI/GTIN: 10193489923612
  • Lot Number: 22JBO006
  • d. C-SECTION CDS
  • Item Number: CDS981430C
  • Case UDI/GTIN: 40193489260879
  • Unit UDI/GTIN: 10193489260878

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 →

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