1,319 recalls tagged with “fda regulated”.
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 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. recalled 46,637 pelvic reconstruction system components nationwide in the United States after MRI safety testing showed higher RF-induced heating than the IFU stated. The issue centers on MRI heating under certain conditions that could injure patients. Patients should stop using the devices and follow manufacturer 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:
ITS GmbH recalled 623 HCS Headless Cannulated Screws distributed nationwide to U.S. healthcare facilities. The defect involves higher RF-induced temperature increases during certain MRI procedures than the IFU described. Affected patients and providers should stop using immediately and follow recall instructions. Contact ITS GmbH or your healthcare provider for instructions.
ITS GmbH recalled 1,307 units of the HLS Hand Locking Plates System distributed nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases. The issue exceeds what is described in the IFU under certain MRI conditions. Patients and healthcare providers should stop using the device immediately and follow ITS GmbH's recall instructions.
I.T.S. GmbH recalled 120 units of its DUL and UOL ulna locking plate systems distributed nationwide to U.S. healthcare providers after MRI safety testing showed higher RF-induced heating. The updated testing found temperature increases under certain MRI conditions not reflected in the Instructions for Use. Healthcare facilities and patients should stop using the devices immediately and follow the厂
Datascope recalled 10,897 CS100 IABP devices worldwide on Jan. 23, 2026. The issue concerns battery runtime and cycle specifications in the device Instructions for Use. Healthcare providers and patients must stop using the device and follow recall instructions.
Datascope Corp. recalls 10,897 CS300 IABP devices sold through healthcare providers worldwide after determining the battery runtime and cycle specifications in the Instructions for Use must be updated. The issue is an information update rather than a device fault. Stop using the device immediately and follow the manufacturer’s recall instructions. Contact Datascope Corp. or your healthcare team to
STAAR Surgical AG recalled 7 EVO+ Visian TICL VTICM5 lenses after finding a labeling error that listed 12.1 mm length but which are 12.6 mm. The mismatch can cause excessive vault and ocular complications. Physicians and patients should stop using the device immediately and follow manufacturer instructions for recall actions.
Agiliti Health recalled 4,286 Adapt Pumps on January 21, 2026, after identifying a malfunction. The issue prevents the Microclimate Management function from re-engaging following the Autofirm function. This defect poses a risk to patients relying on the device for safe pressure management.
Acme United Corporation recalled Med Nap BZK Antiseptic Towelettes, 100-count, distributed nationwide. The FDA-listed CGMP deviations raise concerns about manufacturing quality and product safety. Consumers and healthcare providers should stop using the product and follow the recall letter for guidance.
Dynarex recalled 1,000-pack BZK Antiseptic Towelettes nationwide after CGMP Deviations were identified. The product contains benzalkonium chloride 0.13% and carries NDC 67777-245-04. Consumers should stop using this product immediately and await recall notification by letter.
ACME United recalled WP WipesPlus Hand Sanitizing Wipes, 100-count, sold nationwide, after CGMP deviations were identified. The recall is classified as Class II. Consumers should stop using the product immediately and await guidance from ACME United. The NDC is 67151-727-01.
Nationwide recall of Dukal BZK Antiseptic Towelettes due to CGMP deviations. The products are manufactured for Dukal, LLC in Ronkonkoma, NY and distributed across the United States. Stop using immediately and contact ACME United Corporation for guidance.