Complete FDA and NHTSA recall records dated in June 2022.
These records include useful source details for the selected month.
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…
Reports received of torn corrugated breathing tubes.
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…
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".
Right nails were anodized, marked, and labelled as left nails and vice versa
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.
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
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…
The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to…
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Reports received of torn corrugated breathing tubes.
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
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.
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
Inner pouch seal may be inadequate resulting in lack of sterility.
potential metal fragments in product
Product contains undeclared egg allergen.
Undeclared Allergen - Soy
Undeclared Allergen - Soy
Undeclared milk and tuna. Label declares Hondashi but does not declare Milk and Tuna.
Undeclared wheat. Label declares Hot Bean Paste but does not declared Wheat.
Undeclared soy and wheat. Label declares Hot Bean Paste but does not declare Soy and Wheat.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
