1,215 recalls tagged with “replacement available”.
Medline recall covers 104,004 Medcrest Surgical Gowns sold nationwide and internationally due to premature fabric delamination risk. Delamination can delay patient care in surgery and raise infection risk. Stop using the affected gowns and follow the manufacturer’s recall instructions immediately.
Lutronic's CLARITY II Laser System, 1,525 units distributed worldwide to US clinics and international markets, is recalled. The devices have reports of sparking and popping during use and may burn patients. Clinics and patients should stop using the device immediately and follow the manufacturer's recall instructions.
BD recalled 204,000 10 mL Luer-Lok/Luer Slip syringes due to a packaging mix-up that placed Luer Slip syringes in a batch designated for Luer Lok syringes. The nationwide recall covers products distributed in California and Texas. Healthcare providers and patients should stop using the affected syringes immediately and consult manufacturer recall instructions.
Abiomed recalled 179 Impella RP devices worldwide after a differential pressure sensor may drift. The fault can cause sensor values to drift, potentially affecting patient care. Stop using the device immediately and follow the recall instructions, including contacting Abiomed or your healthcare provider.
Abiomed recalled 291 Impella RP with SmartAssist devices sold worldwide, including the US. A differential pressure sensor may malfunction and cause readings to drift. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Radnostix, Inc. is recalling 16 units of SODIUM IODIDE I-131 Solution distributed nationwide in the United States and Puerto Rico. The product contains particulate matter due to production issues. Healthcare providers and patients should stop using the product immediately and await a recall notification by letter.
Mangalm LLC recalled 40 cases of Tops GOLD Stuffed Red Chilli Pickle, 31.74 oz cans, distributed in California, Nevada, Oregon, Utah and Washington. The recall is due to potential adulteration with erucic acid from mustard oil. Consumers should not consume this product and should contact Mangalm LLC by email for a refund or replacement.
Mangalm LLC recalls 40 cases of Tops GOLD Lime Pickle, 31.74 oz jars, produced in India and distributed to California, Nevada, Oregon, Utah and Washington. The recall follows potential adulteration with erucic acid from mustard oil. Consumers who have purchased the product should not consume it and should contact Mangalm LLC for a refund or replacement via email.
Mangalm recalls Tops GOLD Mango Pickle after FDA enforcement flagged potential erucic acid adulteration. The recall covers two UPCs and two can sizes distributed in five Western states. Consumers are urged not to eat the product and to contact Mangalm for refunds or replacements.
I.T.S. GmbH has recalled 5,568 units of the I.T.S. Screw System sold nationwide in the United States after MRI safety tests showed higher RF-induced temperature increases under some MRI conditions than the IFU outlined. The defect involves MRI RF heating that could burn patients. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.
ITS GmbH recalled 510 units of the I.T.S Straight Plate with Angular Stability after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The recall covers multiple article numbers across forearm and straight plates and distributions nationwide in the United States. No injuries or incidents have been reported at this time. Healthcare providers andpatients
ITS GmbH recalled 176 units nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The issue could cause burns during MRI exposure. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
I.T.S. GmbH recalled 220 Volar Radius Plate PROlock II devices after updated MRI safety testing showed higher RF-induced temperatures under certain MRI conditions. The devices were distributed nationwide in the United States. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.
ITS GmbH recalled 11 Pelvic Reconstruction System PRS components after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU. The recall covers Fixation Screw 70312 and Spike short 70314. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions provided by email.
ITS GmbH recalls 101 Pilon Plate with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate, 4 units, distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
ITS recalls 869 Fibula Plate PROlock with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Hospitals and healthcare providers should stop using this device immediately and follow the recall instructions.
I.T.S. GmbH recalled 322 Claviculaplate with Angular Stability devices sold nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than the IFU reflected. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.
I.T.S. GmbH recalled 12,059 Distal Humeral Plates with Angular Stability due to MRI heating risk. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than reflected in the IFU. Healthcare providers and patients should stop using the device and follow recall instructions.
I.T.S. GmbH recalled 15,517 FLS Foot Locking Plates System and HOL Hallux Osteotomy locking plates distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Patients and healthcare providers should stop using this device immediately and follow the recall instructions from: