95,025 total recalls in our database
Devicor Medical Products
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Stradis Healthcare
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Medtronic Neuromodulation
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.
Smith & Nephew Orthopaedics GmbH
Right nails were anodized, marked, and labelled as left nails and vice versa
International Science & Technology, LP
Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".
Product not approved for release for US distribution
Olympus Corporation of the Americas
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
The device may emit smoke or ignite.
Reports received of torn corrugated breathing tubes.
MEDLINE INDUSTRIES, LP - Northfield
Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.
Product not approved for release for US distribution
Unknown Manufacturer
Screws can become loose and/or detach from the xylophone component of the activity tables, posing a choking hazard to young children.
Unknown Manufacturer
The children's pajamas fail to meet the tight-fitting flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Unknown Manufacturer
The children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Product may contain undeclared peanuts.
California Department of Pesticide Regulation detected the presence of Formetante HCI. This pesticide has a non-tolerance for blackberries.
California Department of Public Health sampled product with a result of Listeria monocytogenes
May contain large and/or sharp fish bones