electronic Recalls

325 recalls tagged with “electronic”.

Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe 61,334 Reverse Shoulder Humeral Liners Recalled Worldwide (2025)

Exactech recalled 61,334 Equinoxe reverse shoulder humeral liners sold worldwide after finding the articular surface position outside labeling dimensions. The recall covers REF 320-38-00, REF 320-38-03, REF 320-42-00, and REF 320-42-03. Healthcare providers and patients should stop using the devices immediately and follow recall instructions distributed by email.

Exactech
Reverse Shoulder
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Health & Personal Care
HIGH
FDA DEVICE

Mindray BeneVision N1 Patient Monitor Recall Issued for 2,278 Units Worldwide (2025)

Mindray DS USA, Inc. dba Mindray North America recalled 2,278 BeneVision N1 patient monitors distributed worldwide, including Canada. The devices may activate an abnormal alarm pause. Hospitals and clinicians should stop using the devices immediately and follow the recall instructions issued by Mindray.

Mindray
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Recalls Heartstring III Proximal Seal System 3.8 mm Occluder (32,867 Units) 0

Maquet Cardiovascular recalls the Heartstring III Proximal Seal System, a 3.8 mm intravascular anastomosis occluder used by hospitals worldwide. Three failure modes have been identified: loading failure, deployment failure, and failure to provide adequate hemostasis. Healthcare facilities should stop using the device immediately and follow manufacturer recall instructions.

Maquet Cardiovascular
Three failure
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ingenuity CT Brazil 728325 CT System Recalled for 3 Units in 2025

Philips recalled 3 Ingenuity CT Family Brazil systems, Model 728325, distributed worldwide, including the United States. A ball screw misalignment after a replacement may cause the patient support table to descend to the lowest position. Hospitals and clinicians should stop using the device and follow Philips recall instructions.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips Brilliance iCT SP CT Systems Recalled for Descending Couch Hazard in 14 Units Worldwide (202

Philips recalled 14 Brilliance iCT SP CT systems, model 728311, sold worldwide including the United States. The patient support couch may descend unexpectedly to the lowermost position because of ball screw misalignment after a replacement. Hospitals should stop using the device immediately and await manufacturer instructions.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips Brilliance CT Systems Recalled for Descent Hazard in 2025 (73 Units)

Philips recalled 73 Brilliance CT systems worldwide after determining a ball screw misalignment could cause the patient couch to descend to the lowermost position. The recall covers Brilliance 16 Power, 728240; Brilliance CT 16 Slice, 728246; and Brilliance CT 6 Slice, 728256. Hospitals and clinics should stop using the devices and follow the manufacturer’s recall instructions immediately.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 600 Hematology Analyzer with HGB Photometer Recalled in 2025

Beckman Coulter recalled the UniCel DxH 600 COULTER Hematology Analyzer configured with an LED HGB Photometer, distributed to laboratories worldwide. The device may produce erroneously high hemoglobin results when WBC counts are elevated. Labs and healthcare providers should stop using the device immediately and follow Beckman Coulter's recall instructions.

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 690T Hematology Analyzer Recall Over HGB Photometer (2025)

Beckman Coulter recalled the UniCel DxH 690T COULTER Cellular Analysis System configured with the LED HGB Photometer REF C34520. The hematology analyzer may produce erroneously high hemoglobin results on samples with elevated white blood cell counts. Labs should stop using the device immediately and follow Beckman Coulter's recall instructions.

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Penner Patient Care's Penner Pacific Bathing Spa Recalled for Missing UDI in 21 Units (2025)

Penner Patient Care, Inc. recalled 21 Penner Pacific Bathing Spa units distributed nationwide in the United States after discovering the devices do not bear a unique device identifier. The missing UDI hinders traceability for adverse events and recalls. Consumers should stop using the devices and contact Penner Patient Care for instructions.

Penner Patient Care
The device
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Health & Personal Care
HIGH
FDA DRUG

Viona Pharmaceuticals Recalls Tavaborole Topical Solution 5% Over Discoloration (2025)

Viona Pharmaceuticals recalls Tavaborole Topical Solution 5% 10 mL bottles, distributed nationwide in the U.S. The effective recall date is August 12, 2025. The product is manufactured by Zydus Lifesciences Ltd. Discoloration was cited as the reason for the recall. Consumers should stop using the product and contact the distributor for guidance.

TAVABOROLE
Discoloration
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Food & Beverages
HIGH
FDA FOOD

Baker's Authority Recalls 78 Units of Three Seed Mix for Sesame Allergen (2025)

Baker's Authority LLC recalls 78 units of Three Seed Mix, 5 lb bags, distributed to multiple states. The recall follows labeling errors that fail to list sesame as an ingredient. Consumers who purchased this product should not consume it and should email Baker's Authority LLC for refund or replacement information.

Baker's Authority
Product label
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Artis Pheno Fluoroscopic X-Ray System Recalled for 20 Units in 2025

Siemens Medical Solutions USA is recalling 20 Artis Pheno image- intensifiied fluoroscopic X-ray systems distributed nationwide. The recall cites limited system movements after startup. Hospitals and healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.

Siemens Medical Solutions USA
Limited system
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Health & Personal Care
HIGH
FDA DEVICE

Max Mobility Permobil MX2+ SpeedControl Dial Recalled for 15,834 Units in 2025

Max Mobility LLC recalls Permobil Smart Drive MX2+ SpeedControl Dial MX2-3DCK affecting 15,834 units sold through multiple retailers. A faulty electrical connection between the speed control dial and the wheelchair motor can cause loss of control. Stop using the device immediately and follow recall instructions; contact Max Mobility LLC or your healthcare provider for instructions. This recall was

Max Mobility
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Medline Medline Extremity Pack DYNJ45701B Sterile Kit Recall Affects 88 Units (2025)

Medline Industries recalled 88 units of the Sterile Extremity Pack DYNJ45701B after finding that kits labeled as sterile had not undergone sterilization. The affected distribution covered Florida, Maryland, New Jersey and Tennessee. Hospitals and clinics should stop using the kit immediately and follow Medline's recall instructions.

Medline Industries
Convenience kits
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Health & Personal Care
HIGH
FDA DEVICE

SeaSpine Orthopedics Recalled 74 Reef TA Inserter Instruments for Reef Interbody System (2025)

SeaSpine Orthopedics recalled 74 Reef TA Inserter instruments used with the Reef Interbody System, distributed worldwide to hospitals and surgical centers. The inserter may cause difficulty disengaging the implant or improper positioning, prolonging surgery and possibly requiring intraoperative revision. Hospitals and surgeons should stop using the device and follow recall instructions from SeaSpn

SeaSpine Orthopedics
Inserter, used
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Health & Personal Care
HIGH
FDA DEVICE

Olympus ViziShot 2FLEX Biopsy Device Recalled for Deformed Tips in 103,731 Units

Olympus Corp of the Americas recalled 103,731 ViziShot 2FLEX single-use aspiration needles worldwide after officials flagged potential undetected, deformed atraumatic tips. The recall covers the NA-U403SX-4019 model. Healthcare providers must halt use immediately and follow manufacturer instructions for recall. Manufacturers say notification was by letter.

Olympus Corporation of the Americas
Potential for
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