Reported Feb 24, 2016 · Terminated
Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal…
Medtronic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Covidien Endo GIA Ultra
- Universal Standard Stapler Handle RefEGIAUSTND
- Product UsageThe Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue
- Lot codes and dates
- RANGES OF LOT NUMBERS (all lot numbers within each range are affected) Lot # starting with P3C through P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X P5E0080X through P5E0082X P5E0317X through P5E0320X P5E0322X through P5E0324X P5F0001X through P5F0002X INDIVIDUAL LOT NUMBERS (in addition to ranges) P5C0239X, P5C0241X, P5C0508X, P5C0510X, P5C0512X, P5C0597X P5C0599X, P5C0601X, P5C0603X, P5C0684X, P5C0803X, P5C0805X, P5C0807X. P5E0527X, P5E0529X P5D0067X, P5D0069X , P5D0073X, P5D0170X, P5D0413X, P5D0415X ,P5D0417X, P5D0419X, P5D0447X, P5D0623X, P5D0624X ,P5D0626X, P5D0628X P5D0630X, P5E0525X, P5F0004X, P5F0006X, P5F0008X, P5F0010X, P5F0014X, P5F0017X, P5F0019X, P5F0021X, P5F0213X, P5F0217X
- Amount recalled
- 1,102,166 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.