replacement available Recalls

1,215 recalls tagged with “replacement available”.

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

Philips Pinnacle3 Recall: 810 Units Over ROI Image Error in 2025

Philips Medical Systems recalled 810 Pinnacle Radiation Therapy Planning System units nationwide to healthcare providers. A software issue may cause an image error of the Region of Interest for HFP, FFS, and FFP orientations. Hospitals and clinics should stop using the software immediately and follow the manufacturer’s instructions.

Philips Medical Systems
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific UroMax Ultra Kit MPNs Recalled Over Foreign Material Migration Risk (2025)

Boston Scientific recalled 1,369 Encore 26 Inflation Devices used with balloon dilation catheters after an internal investigation found foreign material particles could migrate into a balloon dilatation catheter. The recall affects 12 UPNs including M0062251200 through M0062251370. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

Boston Scientific
The Encore
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Health & Personal Care
HIGH
FDA DEVICE

Tandem Diabetes Care Recalls 122,958 t:slim X2 and Tandem Mobi Pumps Over Autobolus Risk (2025)

Tandem Diabetes Care recalled 122,958 insulin pumps nationwide in the United States, including Puerto Rico. A software defect in versions 7.9.0.1 and 7.10.1 for the t:slim X2 and version 7.9.0.1 for the Tandem Mobi paired with a Dexcom G7 sensor can trigger an unexpected automatic insulin correction bolus, raising the risk of hypoglycemia. Users should stop using the affected devices and follow a)

Tandem Diabetes Care
A software
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Health & Personal Care
HIGH
FDA DEVICE

AVID Medical JACK421-04 ENT PACK Recalled for Sterility Risk (2025)

AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.

AVID Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

AVID Medical CPT BASIC IR PACK 1646381 Recall for Sterility Risk (2025)

AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.

AVID Medical
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Wasatch Photonics Raman Spectrometers Recall Expanded for Laser Safety Risks (2025)

Wasatch Photonics recalled 192 Raman spectrometers in the United States after identifying two potential laser safety failure modes. Models 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC, and 785-ER-ILC are included. The defect could occur under excessive force or extreme continuous vibration. Stop using immediately and follow the manufacturer’s recall instructions.

WASATCH PHOTONICS
Two new
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter DxC 500i Clinical Analyzer Modules Recalled for Processing Delays (2025)

Beckman Coulter has issued a recall for 116 DxC 500 AU Module with ISE and DxC 500i components sold internationally. The recall date is 2025-08-04. A processing fault can cause the Clinical Chemistry test to stay In Progress when an Immunoassay test is run between CC tests. Delays may occur. Stop using the device and contact Beckman Coulter for instructions.

Beckman Coulter
On a
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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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Recalled KidKraft Farm to Table Play Kitchen
CRITICAL
CPSC

KidKraft Backyard Kids Farm to Table Play Kitchen Recall 2025 After Strangulation Hazard

Backyard Kids recalled KidKraft Farm to Table Play Kitchens in 2025 after one death was reported at multiple retailers. The hazard arises from hooks that hold toy accessories where clothing can snag during climbing or crawling through the back opening. Stop using the play kitchen immediately and contact Backyard Kids for free replacement hooks or repair.

KidKraft
If young
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Recalled IKEA 365+ VÄRDEFULL garlic press
MEDIUM
CPSC

IKEA 365+ VARDEFULL Garlic Press Recalled for Laceration and Ingestion Hazards (2025)

IKEA is recalling its 365+ VARDEFULL garlic presses after metal fragments can detach and pose a laceration or ingestion hazard. Consumers should stop using the recalled garlic press immediately and return it to any IKEA store for a full refund. If you cannot return to a store, contact IKEA for disposal instructions to receive the refund.

IKEA
Small metal
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Recalled Amazon Basics Premium Foam Eurotop Mattress
HIGH
CPSC

Amazon Recalls Amazon Basics Premium Foam Eurotop Mattress for Fire Hazard (2025)

Amazon recalled Amazon Basics Premium Foam Eurotop Mattresses sold on Amazon. The nine-inch mattresses in twin, full, queen and king sizes were manufactured from 12/22/2022 through 05/16/2024 and violate the federal flammability standard, posing a fire hazard. Stop using the recalled mattress and contact Amazon for a full refund.

Amazon
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls 7,913 Reprocessed ViewFlex Xtra ICE Catheters for Particulates (2025 Recall)

Medline Industries, LP is recalling 7,913 reprocessed ViewFlex Xtra ICE Catheters distributed nationwide in the United States. The lots may contain small residual particulates on patient-contacting surfaces. Healthcare providers and patients should stop using the devices immediately and follow recall instructions to obtain replacement or further guidance.

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

Medline Livewire Steerable EP Catheters Recalled for Particulates in 2025 (7,913 Units)

Medline recalled 7,913 reprocessed Livewire steerable electrophysiology catheters distributed nationwide in the United States. The devices may contain small residual particulates on patient-contacting surfaces, potentially triggering an inflammatory response or systemic infection. Stop using the device and follow recall instructions from Medline or your healthcare provider.

Medline Industries, LP
Specific lots
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Tag Statistics

Total Recalls
1,215

Related Tags

electrical hazardchemical hazardsuffocation riskinfant productadult productchildren productimmediate actionreturn for refundfda regulatedcpsc regulatedtip over riskbattery powered