replacement available Recalls

1,215 recalls tagged with “replacement available”.

Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20 Biplane Recalled for BIOS Battery Failure in 501 Units (2025)

Philips Medical Systems Nederland recalled 501 Allura Xper FD20 Biplane devices sold worldwide to hospitals and healthcare facilities. The BIOS battery may deplete faster during design, halting the startup and preventing the system from starting with no user messages. Healthcare providers and patients should stop using the device and follow the recall instructions from Philips.

Philips Medical Systems Nederland
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems FD20 Biplane OR Table Recall for BIOS Battery Depletion (2025)

Philips Medical Systems Nederland B.V. recalls Allura Xper FD20 Biplane OR Table models 722020 and 722025. Four units are affected worldwide, including two in the United States. The BIOS battery may deplete faster than expected, halting the system startup with no user warning. The recall advises stop-use and coordination with healthcare providers for instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

PHILIPS Allura Xper FD10/10 Recall Tied to BIOS Battery Depletion

Philips Medical Systems Nederland B.V. recalled 585 units of the Allura Xper FD10/10 diagnostic system globally, including 145 in the United States, after reports that the BIOS battery can deplete faster than expected and halt system startup. The recall covers models 722005, 722011, and 722027. Healthcare facilities should stop using the device and follow manufacturer instructions for remediation.

Philips Medical Systems Nederland B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20/20 Recall 115 Units Over Startup-Battery Risk (2025)

Philips Medical Systems Nederland recall 115 Allura Xper FD20/20 imaging systems worldwide after reports that the BIOS battery may deplete prematurely. The startup process may halt with no user alert. Hospitals and providers should stop using affected units and await manufacturer instructions.

Philips Medical Systems Nederland
The BIOS
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Health & Personal Care
HIGH
FDA DRUG

Major Pharmaceuticals Sulfamethoxazole and Trimethoprim 800 mg/160 mg 100-Tablets Recall 2025

Major Pharmaceuticals recalls sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets sold nationwide. A specific lot of packaging coil used in production was found to contain a microorganism in the packaging area, though no microorganism was detected on the tablets. Consumers should stop using the product and follow guidance from Major Pharmaceuticals or their healthcare provider.

Sulfamethoxazole and Trimethoprim
Presence of
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Health & Personal Care
HIGH
FDA DRUG

High-Risk Antibiotic Recall: Sulfamethoxazole and Trimethoprim 800/160 mg Double Strength Packets Re

A high-risk recall of sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets is active nationwide in the United States. The Harvard Drug Group and distribution partners have halted use of a lot due to a foreign-substance finding in packaging material. No tablets tested positive for micro-organisms. Consumers should stop using the product and consult their healthcare providers.

SULFAMETHOXAZOLE AND TRIMETHOPRIM
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

LeMaitre Vascular Artegraft Collagen Vascular Grafts Recall 2025: 28 U.S. Units Affected

LeMaitre Vascular recalled 28 Artegraft Collagen Vascular Grafts distributed nationwide in 17 states. The grafts use bovine carotid arteries sourced from a supplier not reviewed by the appropriate regulatory authority. Patients and healthcare providers should stop using the device immediately and contact LeMaitre Vascular for instructions.

LeMaitre Vascular
The bovine
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Health & Personal Care
HIGH
FDA DEVICE

Canon Medical System SPOT Fluoro Digital Radiography System Recall Affects 8 Units in US (2025)

Canon Medical System, USA recalls 8 SPOT Fluoro digital radiography systems in the United States after a software defect could expose patients to unintended X-ray exposure. The issue occurs when the acquisition program changes and the default ROI causes the collimator and static image to partially cover the collimated area. Stop using the affected devices and follow manufacturer instructions for a

Canon Medical System
It has
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Health & Personal Care
HIGH
FDA DEVICE

BigTree Sales Recalls BT-GERMWAND-LRG-WHT UV-C Wand for Unsafe Radiation Risk (2025)

BigTree Sales recalled its BT-GERMWAND-LRG-WHT handheld UV-C germicidal wand sold in the United States after FDA enforcement flagged unsafe UVC emissions. The device reaches the exposure limit for Risk Group 3 in about 2.2 minutes, creating a risk of skin and eye injuries. Stop using the device immediately and follow the recall instructions provided by the manufacturer.

BigTree Sales
The subject
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Recalled 561 Units of NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy C

Northeast Scientific recalled 561 units of NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. The recall covers all lots within shelf life ending before August 29, 2026. The hazard is breaches in sterile barrier packaging that could compromise sterility. Stop using the device and follow manufacturer instructions for return or replacement.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Fresenius Medical Care Optiflux Dialyzers Recalled for Press-On Cap Issue (172,494,732 units, 2025)

Fresenius Medical Care recalls 172,494,732 Optiflux High Flux E-beam Dialyzers distributed nationwide in the United States. Caps on these dialyzers were changed from threaded to press-on versions, requiring users to press the caps firmly to secure them. Patients and healthcare providers should stop using these devices immediately and follow recall instructions issued by the manufacturer.

Fresenius Medical Care Holdings
To provide
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Laser Atherectomy Catheter Recalled for Sterile Barrier Breach Risk (2025)

Northeast Scientific recalled 165 units of the NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter sold nationwide in the United States. The recall cites the potential breach of sterile barrier packaging that could compromise sterility. The device is not cleared for marketing in the U.S. and has a high-risk hazard designation. Patients and healthcare providers should stop using the产品,

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter Recall 2026

Northeast Scientific recalled 141 units of the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter nationwide in the United States. The device may have breaches in the sterile barrier packaging that could compromise sterility. Hospitals and patients should stop using the device immediately and await instructions from Northeast Scientific Inc. or their clinicians.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter Recall 2025

Northeast Scientific recalled 795 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheters nationwide. The device is not cleared for marketing in the United States. The recall cites breaches in sterile barrier packaging that could compromise sterility. Hospitals and providers should stop using the device immediately and follow manufacturer instructions.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalled 473,040 CLEARLINK IV Solution Sets for Leakage Risk (2025)

Baxter Healthcare Corporation is recalling 473,040 CLEARLINK SYSTEM CONTINU-FLO IV Solution Sets sold nationwide to healthcare providers. The IV sets may leak, increasing the risk of improper fluid administration. Stop using the product immediately and contact Baxter Healthcare Corporation or your healthcare provider for instructions.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls 136,512 CLEARLINK IV Sets DUO-VENT for Leak Risk (2025)

Baxter Healthcare recalled 136,512 CLEARLINK System Solution Set DUO-VENT IV sets distributed nationwide in the United States after detecting a leak risk. The Luer Activated Valve design may leak, potentially compromising IV administration. Hospitals and patients should stop using the device immediately and follow Baxter recall instructions.

Baxter Healthcare
IV sets
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