electronic Recalls

325 recalls tagged with “electronic”.

Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter Recall 173 Un­

Northeast Scientific recalled 173 units of the NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter distributed nationwide to U.S. healthcare facilities. The device is not cleared for marketing in the United States due to sterility concerns. A breach in the sterile barrier packaging could compromise sterility. Health care providers and patients should stop using the device immediately.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls 8,368 CLEARLINK CONTINU-FLO IV Sets for Leakage Risk (2025)

Baxter Healthcare recalled 8,368 CLEARLINK SYSTEM CONTINU-FLO IV sets nationwide after reports the devices may leak. The non-vented sets include a 0.2-micron filter, three CLEARLINK luer activated valves and a backcheck valve, and measure 102 inches in length. Hospitals and clinicians should stop using these units immediately and follow Baxter's recall instructions.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

ConvaTec DuoDERM Extra Thin Dressings Recalled in 2025 for Foreign Matter

ConvaTec recalled 80,980 DuoDERM Extra Thin wound dressings distributed nationwide in the United States. The dressings may contain foreign matter, which could compromise wound care. Healthcare providers and patients should stop using the dressings and follow recall instructions.

ConvaTec
Wound dressing
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Health & Personal Care
HIGH
FDA DEVICE

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter Recall: 616 Units In US Distribution

Northeast Scientific Inc. has issued a recall for 616 units of the NES Reprocessed Turbo-Elite Laser Atherectomy Catheter, Model R-417-156. The FDA-listed recall cites breaches in sterile barrier packaging that could compromise sterility. The devices were distributed nationwide in the United States to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, and VA. Patients should not be in

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Verio Dot MRI Recall 30 Units Over Ice Blockage Risk (2025)

Siemens Medical Solutions USA recalled 30 MAGNETOM Verio Dot MRI systems sold worldwide through hospitals and medical facilities. The ice blockage in the magnet venting system could trap helium during a quench, causing pressure buildup and a potential helium leak into the scanning room. Facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Skyra fit MRI Recalled for Ice Blockage Risk in 30 Units (2025)

Siemens Medical Solutions USA recalled 30 MAGNETOM Skyra fit MRI units worldwide after identifying an ice blockage in the magnet venting system. The defect could prevent helium venting during a quench, causing pressure buildup that may rupture the helium containment and leak into the scanning room. Hospitals should stop using the affected devices immediately and follow the manufacturer’s recall,咨询

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Vida MRI Recall 237 Units Worldwide Over Ice Blockage Risk (2025)

Siemens Medical Solutions USA recalled 237 MAGNETOM Vida MRI scanners sold worldwide to healthcare providers. The recall cites ice forming in the magnet venting system. A quench could lead to a helium leak into the scanning room. Hospitals must stop using the devices and await manufacturer instructions.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems MAC VU360 Recall 29,225 Trunk Cable and Module Holder Units (2025)

GE Medical Systems recalled 29,225 MAC VU360 Acquisition Trunk Cable and Module Holder devices worldwide. The defect can occur when a user inserts the Acquisition Module incorrectly, causing excessive bending and wear of the Acquisition Trunk Cable. A damaged sheath or exposed wires may appear. If a damaged cable is not identified and removed from service, it can overheat. Stop use immediately and

GE Medical Systems
If a
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Health & Personal Care
HIGH
FDA DEVICE

Abbott i-STAT CG8+, EG7+, EG6+ Cartridges Recalled in 2025 Over Missing 510(k) Clearance

Abbott Point Of Care recalled 547,250 i-STAT CG8+, EG7+, and EG6+ cartridges distributed nationwide in the United States. The recall concerns lack of 510(k) premarket clearance for updated sample types and measurement ranges. Hospitals and clinicians should stop using these cartridges immediately and follow Abbott’s recall instructions.

Abbott Point Of Care
Lack of
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Health & Personal Care
HIGH
FDA DEVICE

Bard Peripheral Vascular Venclose DigiRF Generator Recall Affects 1,725 Units Worldwide

Bard Peripheral Vascular recalled 1,725 Venclose digiRF Generators with software version 3.35. The recall centers on a catheter verification feature that can produce false positives and disable compatible EVSRF catheters. The worldwide distribution includes the United States. Patients and healthcare providers should stop using the device and await further instructions from the manufacturer.

Bard Peripheral Vascular
Software version
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recall 10,833 Units in 2025 Over Software Hazard

Boston Scientific recalled 10,833 pacemakers worldwide after a software issue could block Safety Mode in an ambulatory setting. The defect affects the ACCOLADE family and related devices, including VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled in 2025 for Safety Architecture Software Flaw

Boston Scientific recalled 34,180 devices worldwide on 2025-08-20 for ACCOLADE family pacemakers and CRT-Ps due to software that could prevent Safety Mode in high battery impedance conditions. The defect affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and EL models, plus VISIONIST and VALITUDE CRT-P devices. Patients should stop using the devices and follow recall instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemaker Recall 2025 Affects 41,191 ACCOLADE, Visionist and Valitude Devices

Boston Scientific is recalling 41,191 ACCOLADE family pacemakers and Visionist and Valitude CRT-P devices worldwide. The software to enhance Safety Architecture could prevent Safety Mode activation in ambulatory settings when a high battery impedance state is present. Patients should stop using the device and contact their healthcare provider for instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific ESSENTIO DR EL MRI Pacemaker Recalled for Software Safety Issue (190,088 Units, 0)

Boston Scientific recalled 190,088 pacemakers worldwide, including ACCOLADE family devices and related CRT-Ps. The software to enhance Safety Architecture could prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state. Patients and healthcare providers should stop using these devices immediately and await manufacturer instructions by letter.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemaker Recall Affects 3,620 Units Worldwide in 2025

Boston Scientific recalls 3,620 pacemakers worldwide including VALITUDE CRT-P EL and ACCOLADE family devices. A software update is intended to prevent initiation of Safety Mode due to high battery impedance. Patients and clinicians should stop using affected devices and await manufacturer instructions.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Pacemakers Recalled for Safety Architecture Software Issue (41,009 Units, 2025)

Boston Scientific recalled 41,009 pacemakers worldwide after a software flaw could prevent Safety Mode activation. The defect affects devices in the ACCOLADE family and several related models. Patients and healthcare providers should stop using the device immediately and follow recall instructions from the manufacturer.

Boston Scientific
Software to
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Health & Personal Care
HIGH
FDA DEVICE

Corneat Vision EverPatch+ 180-Unit Recall for Scleral Patch Dehiscence Risk (2025)

CORNEAT VISION recalled 180 units of EverPatch+ scleral reinforcement patch worldwide after complaints of conjunctival wound dehiscence. The issue can lead to early exposure of the surgical patch. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.

CORNEAT VISION
Reviewed complaints
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Health & Personal Care
HIGH
FDA DEVICE

Maquet Cardiovascular Heartstring III Proximal Seal System Recalled for 168 Units Worldwide (2025)

Maquet Cardiovascular recalled 168 Heartstring III Proximal Seal System intravascular occluders worldwide, including the United States. Three failure modes have been identified: loading the Heartstring Seal, deploying it into the aortotomy, and achieving adequate hemostasis. Healthcare facilities should stop using the device and follow the manufacturer’s recall instructions.

Maquet Cardiovascular
Three failure
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Tag Statistics

Total Recalls
325

Related Tags

immediate actionstop use immediatelyreplacement availablefda regulatedcpsc regulatedglassmetalplasticbattery poweredsuffocation riskreturn for refundworkplace