Class I - Dangerous
Devices are not consistent with Quality System Requirements.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Insufficient documentation to support product sterility claims.
Class I - Dangerous
Insufficient documentation to support product sterility claims.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Devices are not consistent with Quality System Requirements.
Class I - Dangerous
Insufficient documentation to support product sterility claims.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Sorin Group USA
Class I - Dangerous
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
Stryker Neurovascular
Class I - Dangerous
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Sorin Group USA
Class I - Dangerous
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Class I - Dangerous
A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
Complaint of the head holder connector locking up mechanically when tightened.
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Greatbatch Medical
Class I - Dangerous
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Sorin Group USA
Class I - Dangerous
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.