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.
30,447 detailed records are currently available in this category.
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while…
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.
Product lot did not meet the specification for its disinfectants at the time of manufacture.
The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked)…
The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while…
Package inserts have incorrect SmartWash parameters for Triglyceride.
There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.
One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.
Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.
MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been…
Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent…
Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.
It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the…
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the…
Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains one…
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility…
Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless…
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not…
The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety…
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints…
The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .
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.
