The Recall Desk
HighFDA (Devices)·Z-1076-2023·Announced 2023-02-15

Sterile Procedural Trays Recalled Due to Blade Puncture Risk

Medline Industries is recalling sterile procedural trays (ENDOSCOPY-LF and SEPTO/ENDO) because sterile blades may puncture the outer foil layer of the sterile packaging. The recall affects units 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 Class II medical device recall involving a risk-of-harm product (sterile procedural trays where packaging sterility could be compromised). No illnesses or injuries have been reported, placing this at the High severity level per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Medline Industries, LP is recalling Sterile Procedural Trays labeled as ENDOSCOPY-LF and SEPTO/ENDO. The sterile blades within these kits have the potential to puncture the outer foil layer of the sterile packaging, which could compromise the sterility of the contents.

The affected products have been distributed worldwide, including throughout the United States, Canada, Japan, Mexico, Panama, Turks and Caicos, and the United Arab Emirates.

Healthcare facilities that have received the affected lot numbers (22JBM081 for ENDOSCOPY-LF and 22JBP701 for SEPTO/ENDO) should contact Medline Industries regarding the recall. Compromised sterile packaging may allow contamination to occur, which could affect the safety and efficacy of medical procedures using these trays.

The recalled product

Product
Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Procedural Trays
Hazard
  • blade-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 (10)

  • a. ENDOSCOPY-LF
  • Item Number: DYNJ22890M
  • Case UDI/GTIN: 40193489766487
  • Unit UDI/GTIN: 10193489766486
  • Lot Number: 22JBM081
  • b. SEPTO/ENDO
  • Item Number: DYNJ902831D
  • Case UDI/GTIN: 40193489231671
  • Unit UDI/GTIN: 10193489231670
  • Lot Number: 22JBP701

Distribution

Distributed nationwide across the United States.

Related recalls

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