325 recalls tagged with “electronic”.
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 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 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.
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.
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
Green Guard Antiseptic Wipes, distributed nationwide by ACME United Corporation, are being recalled as of January 20, 2026. FDA enforcement cites CGMP deviations in manufacturing for the benzalkonium chloride wipes, NDC 47682-056-73. Consumers and healthcare providers should stop using the product immediately and contact ACME United for guidance on refunds or replacements.
Siemens Healthcare Diagnostics recalled 4,885 Atellica CH Urine Albumin tests in 2026 after detecting falsely depressed results. The manufacturer notes that any urine albumin concentration above 40.0 mg/dL may report values from 6.2 to 40.0 mg/dL. Stop using the device immediately and follow the recall instructions.
Instrumentation Laboratory is recalling 25 GEM PAK cartridges for the GEM Premier 5000 after complaints of PCSND errors during warm-up. The issues can cause consecutive GEM PAK ejections. The recall affects units distributed worldwide to healthcare facilities. Stop using the affected cartridges and follow manufacturer instructions.
Instrumentation Laboratory recalled 1,225 GEM Premier 5000 PAK cartridges worldwide on 2026-01-20 after concerns of PCSND errors during warm-up. The errors can trigger GEM PAK cartridge ejection and may require insertion of a new PAK, delaying results. Stop using the device immediately and follow the manufacturer’s recall instructions.
Instrumentation Laboratory is recalling 30 GEM Premier 5000 PAK cartridges distributed worldwide, including the United States. The affected cartridges may experience PCSND errors during warm-up, causing GEM PAKs to eject. Stop using the product and follow recall instructions from the manufacturer for refunds or replacements.
Instrumentation Laboratory recalls 180 GEM Premier 5000 PAK cartridges distributed worldwide after reports of PCSND errors during warm-up. During warm-up, GEM PAKs may eject and require insertion of a new GEM PAK. Hospitals should stop using the affected cartridges and follow the manufacturer's recall instructions.
Instrumentation Laboratory’s GEM Premier 5000 was recalled for 195 units distributed worldwide to hospitals and clinical labs. The recall follows complaints of increased Process Control Solution Not Detected errors during warm-up, which can eject GEM PAK cartridges. Hospitals should stop using the device immediately and contact IL for instructions.
Instrumentation Laboratory recalled 130 GEM PAK cartridges for the GEM Premier 5000 after confirmed complaints of Process Control Solution Not Detected errors during warm-up. The issue can cause GEM PAKs to eject and delay test turnaround. Healthcare facilities should stop using the affected cartridges and follow manufacturer instructions for recall guidance.
Instrumentation Laboratory recalled seven GEM Premier 5000 units worldwide, including the US. PCSND errors during warm-up may cause GEM PAK cartridges to eject, potentially delaying results. Healthcare providers using these devices should stop using the affected units and contact IL for instructions and a remedy.
GE Healthcare recalled 250 Centricity Universal Viewer Zero Footprint Client units distributed worldwide after finding a risk that patient information may not match displayed images in certain workflows. The issue affects ZFP v6.0 SP11.6, SP11.6.0.1 and SP11.6.1 when Patient Timeline is installed. Hospitals should stop using affected units and await instructions from GE Healthcare.
Waldemar Link GmbH & Co. KG recalls its Endo-Model Replacement Plateau implant. Three units are affected worldwide, including New Jersey in the United States. The defect allows a bushing to detach from the screw shaft after a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall instructions. Notification was sent by,
Waldemar Link recalled 1 unit of Endo-Model Replacement Plateau worldwide, including the United States in New Jersey. The device could detach its bushing from the screw shaft because of a longitudinal fracture. Clinicians and patients should stop using the device and await manufacturer instructions.
Medline Industries recalled 31,848 dialysis dressing change kits on January 8, 2026. The recall follows reports of defective silicone seals on Tego Connectors that may occlude fluid paths. This defect can delay therapy and expose patients to biological contaminants.
Olympus Corp. of the Americas recalls 55 ShockPulse-SE Lithotripsy System units distributed internationally. Mis-wired component may create noise on the power supply and ultrasonic circuit. Hospitals and providers should stop using the device immediately and follow recall instructions. Notify Olympus or your healthcare provider for guidance.