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Recall Observatory FDA recall evidence

Device product

PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP

Z-1513-2025

March 07, 2025

Class II

Product summary

Firm
Ethicon Endo Surgery, LLC
Event
Event 96461
Status
Ongoing
Classification
Class II
Quantity
792 units
Official record key
device-enforcement:Z-1513-2025

Official wording

Reason: Identified curing issues with the silicone during the needles manufacturing process.

Code information: Product Code: PDP127H-14; GMDN: 47362; UDI-DI: 10705031047907; Lot number: 104M7E;

Distribution pattern: Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, Uruguay.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Identified curing issues with the silicone during the needles manufacturing process.