Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
All Recalls
92,900 total recalls in our database
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Medtronic Neuromodulation
Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Ethicon Sarl, a Johnson & Johnson Company
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Baxter Healthcare
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
BISSELL® Steam Shot™ Handheld Steam Cleaners
Unknown Manufacturer
The recalled steam cleaners can expel hot water or steam onto users while heating or during use, posing a burn hazard.
CFMOTO ZFORCE 950 HO Sport Side-by-Side ROVs (2022-2023)
Unknown Manufacturer
The shock absorber rod assembly can unthread and detach, causing suspension collapse, posing crash and tip-over hazards to the rider.
Brilliant Bee Rattles
Unknown Manufacturer
The wooden base can detach from the wooden rod and release the three plastic rings, posing a choking hazard to young children.
Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz cans
Dairy Manufacturers
The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. Cronobacter spp. detected by FDA sampling.
Hudson Harvest Tomato Basil Sauce, 16 oz., UPC # 683720301567
Hudson Harvest Wholesale
Jarred sauce may be under-processed.
Arepas La Mejor, Arepa de Chocolo (Chocolate Sweet Corn Pancakes), NET WT. 25 Oz., 5 units per package, KEEP REFRIGERATED
Villa Nueva Interservices
Undeclared allergens: Milk
C. Kreuger Gluten Free White Chocolate Cherry Oatmeal Cookies, 2oz in plastic sleeve. 60 cookies per case. Storage for 30 days at ambient and 1 year frozen.
C. Krueger Finest Baked Goods
No ingredient statement on the label.
The product has cross contamination with peanuts.
7-Eleven Simply Egg Salad Sandwich, Keep Refrigerated, Flexible Packaging, 6.8oz (193g)
Taylor Farms Northwest
Undeclared milk
Farmalac powdered infant formula with iron 12.4 oz cans
Dairy Manufacturers
The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.