Tracheopart Set (Left), Sterile
Teleflex
Class I - Dangerous
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Draeger Medical
Class I - Dangerous
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Class I - Dangerous
The double swivel connector may crack or separate on the endobronchial tube.
Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Stryker Howmedica Osteonics
Class I - Dangerous
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
Stryker Howmedica Osteonics
Class I - Dangerous
A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
GE Optional Laser Centering Device X-ray generator.
GE Inspection Technologies
Class I - Dangerous
GE has identified a potential failure to comply with 21 C.F.R. Âŋ 1040.10 and 21 C.F.R. Âŋ 1010.2 for the alignment laser centering device.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Class I - Dangerous
AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
Class I - Dangerous
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Class I - Dangerous
The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken.
Class I - Dangerous
AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Fresenius Medical Care Holdings
Class I - Dangerous
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
Class I - Dangerous
AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
Class I - Dangerous
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.