Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
29,963 detailed records are currently available in this category.
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.
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Potential breach of the sterile barrier packaging.
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
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 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…
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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 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.
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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.
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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.
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
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.
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.
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
