🏥 Medical Devices • 15,809 recalls
Becton Dickinson & Company
Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifications. Stoppers were manufactured with a reduced cycle cure time.
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
American Science & Engineering
During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being produced but the X-ray indicator lights (located on the operator's console and on both ends of the tunnel) are not illuminated.
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Teleflex Medical
The double swivel connector may crack or separate on the endobronchial tube.
Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Teleflex
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
Draeger Medical
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
The double swivel connector may crack or separate on the endobronchial tube.
Stryker Howmedica Osteonics
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.
GE Inspection Technologies
GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
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.
The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat where the wall bracket has cracked or broken.
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.
Fresenius Medical Care Holdings
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.