fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

CorNeat Vision EverPatch Recalled for Conjunctival Wound Dehiscence Risk (630 Units, 2025)

CorNeat Vision recalled 630 EverPatch surgical matrices distributed worldwide, including in 28 U.S. states. Review of complaints found conjunctival wound dehiscence may lead to early exposure of the patch. Stop using the device immediately and follow the manufacturer’s recall instructions. Contact CORNEAT VISION, LTD. or your healthcare provider for guidance.

CorNeat Vision
Reviewed complaints
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Health & Personal Care
HIGH
FDA DEVICE

Aesculap AG Recalls ELAN 4 Fixed Duraguard Long Mislabeling Devices (GB943R)

Aesculap AG recalls the ELAN 4 Fixed Duraguard Long device, Model GB943R, after mislabeling errors were discovered. The U.S. distribution reached Missouri with international distribution to multiple countries. Healthcare providers should stop using the device immediately per manufacturer instructions.

Aesculap AG
Mislabeling. The
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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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Food & Beverages
HIGH
FDA FOOD

Tampa Maid Foods Frozen Shrimp Recalled for Cs-137 Contamination (2025)

Tampa Maid Foods recalled 776 cases of Panko Style Breaded Butterfly Shrimp due to potential Cesium-137 contamination. The product was distributed to 16 states. Consumers should not eat the shrimp and should contact the company for refunds or replacements.

TAMPA MAID FOODS
Product may
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Food & Beverages
HIGH
FDA FOOD

ADMIRAL OF THE FLEET, PORTICO SEAFOOD CLASSIC Breaded Shrimp Recalled Over Cs-137 Contamination (120

ADMIRAL OF THE FLEET and PORTICO SEAFOOD CLASSIC Cleantail Breaded Butterfly Shrimp is recalled by TAMPA MAID FOODS, LLC after the FDA identified Cesium-137 contamination. The recall covers 1,200 cases distributed to multiple states. Consumers should not consume the product and should contact TAMPA MAID FOODS for refund or replacement.

ADMIRAL OF THE FLEET
Product may
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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

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

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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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

Ethicon Stratafix PDS Plus Recall 516 Units for Barb Non-Engagement (2025)

Ethicon recalled 516 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Devices sold worldwide through healthcare providers, including 18 U.S. states and Singapore and Malaysia. The defect is potential barb non-engagement that could compromise tissue control. Clinicians and patients should stop using the device immediately and follow recall instructions from Ethicon.

Ethicon
Potential for
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Food & Beverages
HIGH
FDA FOOD

Great Value and Sea Best Raw Frozen Shrimp Recalled for Cs-137 Contamination (33,164 Lbs) 2025

Beaver Street Fisheries is recalling 33,164 pounds of Great Value and Sea Best raw frozen shrimp distributed to Arkansas, Florida and Illinois after Cs-137 contamination was detected. The product may be contaminated with Cesium-137, a radiological hazard. Consumers should not consume it and should contact Beaver Street Fisheries for refund or replacement.

Great Value
Product may
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Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Tuscan Artichoke and Mozzarella Salad Recalled for Undeclared Allergens (8.5 oz)

Fresh & Ready Foods recalled 233 units of Tuscan Artichoke and Mozzarella Salad distributed to 15 California locations after undeclared wheat and milk allergens were found. The allergen was not declared on the label. Consumers should not eat the product and should contact Fresh & Ready Foods LLC for refunds or replacements via email.

Fresh & Ready Foods
undeclared allergen
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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 DRUG

Novartis/Sandoz Otic Suspension Recalled for Temperature Abuse (D-0626-2025)

Novartis Manufacturing NV and Sandoz Inc recall ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension after temperature abuse. The recall affects one consignee in California. Consumers and health care providers should stop using the product immediately and follow guidance from Sandoz or a healthcare provider.

CIPROFLOXACIN AND DEXAMETHASONE
Temperature Abuse
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter DxH 900 COULTER Hematology Analyzer Recalled for Inaccurate Hemoglobin Results

Beckman Coulter recalled hematology analyzers configured with HGB photometers after reports of erroneously high hemoglobin results in samples with elevated WBC counts. The recall covers DxH 900 systems worldwide. Stop using the device immediately and follow manufacturer instructions. Contact Beckman Coulter or a healthcare provider for guidance.

Beckman Coulter
Hematology analyzers
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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 IQon Spectral CT 728332 Recalled Globally for Descending Patient Table Hazard

Philips North America has issued a recall for 81 IQon Spectral CT systems, Model 728332, sold worldwide. The patient support table may descend unexpectedly to the lowest position due to ball screw misalignment after a replacement. Stop using the device immediately and follow manufacturer recall instructions.

Philips North America
The patient
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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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Tag Statistics

Total Recalls
1,264

Related Tags

adult productstop use immediatelyreplacement availablereturn for refundcpsc regulatedimmediate actionsuffocation risklaceration riskelectrical hazardplasticglasswood