tip over risk Recalls

243 recalls tagged with “tip over risk”.

Health & Personal Care
HIGH
FDA DEVICE

Exactech Equinoxe Recalled 11,542 HumeraL Liners Worldwide Over Dimension Mismatch (2025)

Exactech recalled 11,542 Equinoxe reverse shoulder humeral liners worldwide after finding the articular surface position outside labeling specifications. The recall covers several REF numbers and UDIs and is active as of 2025. Healthcare providers were advised to stop using affected liners and follow manufacturer instructions.

Exactech
Reverse Shoulder
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter UniCel DxH 800 Hematology Analyzers Recalled for High Hemoglobin Readings in High-WB

Beckman Coulter recalled the UniCel DxH 800 COULTER Cellular Analysis System configured with the Led HGB photometer. The recall affects models B24802, 629029, and B63322 and related configurations. A design-linked issue can yield erroneously high hemoglobin results when samples have elevated white blood cell counts. Stop using the device and follow the manufacturer’s recall instructions. Contact a

Beckman Coulter
Hematology analyzers
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT Systems Brilliance 40/64 Channel and Ingenuity Flex Recalled for Couch Descent Risk (2025

Philips North America LLC is recalling 181 CT systems worldwide, including Brilliance CT 40 Channel 728235, Brilliance CT 64 Channel 728231, and Ingenuity Flex 728317. The patient support couch may descend to the lowermost position after a replacement. Hospitals and imaging centers should stop using the devices immediately and await recall instructions.

Philips
The patient
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Health & Personal Care
HIGH
FDA DEVICE

Philips CT Systems Recalled for Descent Hazard In 210-Unit Worldwide Distribution (2025)

Philips North America recalls 210 CT systems worldwide after reports that the patient support couch may descend unexpectedly to the lowest position following a replacement. Philips issued a recall dated 2025-08-13 with active status. The recall number is Z-2598-2025. Stop using immediately and follow manufacturer instructions.

Philips North America
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

Max Mobility/Permobil Recalls 8,413 Smart Drive MX2+ SpeedControl Dials (2025)

Max Mobility LLC recalls 8,413 Smart Drive MX2+ SpeedControl Dials used with the SmartDrive MX2+ Wheelchair Power Assist. A faulty electrical connection between the dial and the motor can cause loss of control. Stop using the device immediately and follow recall letters for instructions.

Max Mobility
Due to
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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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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Encore 26 Inflation Device Recalled Over Foreign Particle Contamination

Boston Scientific recalls 39,739 Encore 26 Inflation Devices worldwide after an internal investigation found foreign material particles could migrate from the device into balloon dilation catheters. The high-severity recall affects interventional cardiology and peripheral interventions devices. Stop using immediately and await recall instructions from Boston Scientific or healthcare providers.

Boston Scientific
The Encore
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific NephroMax Kit Recall Covers 458 Units Over Foreign Material Migration Risk

Boston Scientific Corp. recalls 458 NephroMax Kit units using Encore 26 Inflation Devices after an internal review found foreign material particles could migrate from the inflation device into balloon dilatation catheters. The recall affects UPNs M0062101180 and M0062101600 worldwide. Healthcare providers should stop using the device immediately and follow manufacturer recall instructions.

Boston Scientific
The Encore
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Health & Personal Care
HIGH
FDA DRUG

Hospira Epinephrine Injection Vials Recalled for Lack of Sterility Assurance (2025)

Hospira recalls 49,620 vials of Epinephrine Injection, distributed nationwide in the United States. The recall, active since August 4, 2025, targets vials with NDC 0409-4933-05 and case NDC 0409-4933-10. The hazard is lack of assurance of sterility. Health professionals should stop using the product and contact Pfizer or a healthcare provider for guidance.

Epinephrine
Lack of
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Health & Personal Care
HIGH
FDA DEVICE

Waldemar Link Recall Reaches 8 Units of LinkSymphoKnee Tibial Components Over Uncoated Screws (2025)

Eight modular LinkSymphoKnee TiNbN tibial components are under recall after production with two uncoated security screws. Waldemar Link GmbH & Co. KG disclosed the issue. The devices were distributed worldwide, including CO, IN, NJ and TX in the United States, plus Germany and Italy. Consumers should stop using the device immediately and follow manufacturer instructions.

Waldemar Link GmbH & Co. KG
Some modular
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalled 7,913 Reprocessed Webster CS Catheters for Electrophysiology Mapping

Medline Industries recalled 7,913 reprocessed Webster CS Catheters for electrophysiology mapping nationwide in the United States. The recall concerns small residual particulates on patient-contacting surfaces that could trigger inflammatory responses or systemic infection. If particulates dislodge and contact circulating blood or the heart, they could cause granulomatous reactions or thrombus, and

Medline Industries, LP
Specific lots
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Health & Personal Care
HIGH
FDA DEVICE

Fortress Introducer Sheath System 386594 Recall Expanded; 2,500 Units Worldwide Distribution (High-R

Fortress Introducer Sheath System recalled 2,500 units linked to label mispackaging. The devices were distributed worldwide, including 15 U.S. states and numerous international markets. The incorrect pouch label lists the 4F version reference and unique device identifier instead of the packaged 6F version. Healthcare providers must stop use and follow manufacturer recall instructions.

Fortress Introducer Sheath System
Units may
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