There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Class IReported ongoing
Distribution: Worldwide distribution. US nationwide including Guam, USVI, and Puerto Rico; Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Den...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Class IIReported ongoing
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bul...
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tiss...
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Canada Canary Islands Chile Croatia Cyprus Denmark Egypt Finland France Germany Greece Hungar...
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tiss...
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Canada Canary Islands Chile Croatia Cyprus Denmark Egypt Finland France Germany Greece Hungar...
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide.
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the m...
Class IIReported ongoing
Distribution: The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and uninte...
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
These examples come from this result page and are not a ranking of every recall reason.
Checking Covidien, LP
Is there a recall on covidien, lp right now?
This archive contains 76 records, including 76 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included?
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record?
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.