Data Foundry

Medical device recalls 2019

Integra Jarit GEMINI CLAMP 9 1/4 inch — Class II medical device recall Z-2435-2019

Terminated recall by Integra LifeSciences Corp., reported 2019-09-11, distributed nationwide. A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased

Recall numberZ-2435-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntegra LifeSciences Corp., Plainsboro, NJ, United States
Recall initiated2019-08-07
Classified2019-08-30
Reported by FDA2019-09-11
Terminated2020-06-24
DistributedNationwide (US)
Quantity237 units
Reason classespackaging, device malfunction
Lot numbersAA1901
Model numbers140-332

Product

Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332

Reason for recall

A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2435-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.