fda regulated Recalls

1,260 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Max Mobility Permobil MX2+ SpeedControl Dial Recalled for 15,834 Units in 2025

Max Mobility LLC recalls Permobil Smart Drive MX2+ SpeedControl Dial MX2-3DCK affecting 15,834 units sold through multiple retailers. A faulty electrical connection between the speed control dial and the wheelchair motor can cause loss of control. Stop using the device immediately and follow recall instructions; contact Max Mobility LLC or your healthcare provider for instructions. This recall was

Max Mobility
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Artis Pheno Fluoroscopic X-Ray System Recalled for 20 Units in 2025

Siemens Medical Solutions USA is recalling 20 Artis Pheno image- intensifiied fluoroscopic X-ray systems distributed nationwide. The recall cites limited system movements after startup. Hospitals and healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.

Siemens Medical Solutions USA
Limited system
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Food & Beverages
HIGH
FDA FOOD

H & N Group Frozen Shrimp Recalled for Cs-137 Contamination (2025)

H & N Group recalled 17,214 cases of frozen shrimp distributed to East Coast retailers after potential Cs-137 contamination. The product was manufactured under insanitary conditions. Consumers should not eat this product and should contact H & N Group for refund or replacement by telephone.

H & N Group
Product manufactured
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Health & Personal Care
HIGH
FDA DEVICE

Max Mobility/Permobil Recalls 25,389 MX2+ SpeedControl Dial Units (2025)

Max Mobility LLC and Permobil recalled 25,389 MX2-3DC SpeedControl Dial units used with the SmartDrive MX2+ wheelchair power assist. A faulty electrical connection between the speed control dial and the wheelchair motor can cause loss of control. Users should stop using the device immediately and follow the manufacturer’s recall instructions for next steps.

Max Mobility
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Applied Medical Technology NutraGlide ENFit Nasal Feeding Tube Recall 840 Units (2025)

Applied Medical Technology recalled 840 NutraGlide ENFit nasal feeding tubes distributed in the United States to Massachusetts and Rhode Island. The tubes have distal tips that may detach at lower than expected forces. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.

Applied Medical Technology
The nasal
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Health & Personal Care
HIGH
FDA DEVICE

Agilent FLEX Monoclonal CD20 Antibody Recalled for 4,145 Units (2025)

Agilent Technologies Denmark ApS recalled 4,145 FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use antibodies distributed nationwide in the United States. The defect is a potential for weak staining that can yield a false negative CD20 result. Labs should stop using the product immediately and follow manufacturer recall instructions.

Agilent Technologies
Their is
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Health & Personal Care
HIGH
FDA DEVICE

Agilent Technologies Recalls 65 FLEX Monoclonal CD20 Antibodies Over Weak Staining Risk (GA60461-2CN

Agilent Technologies recalled 65 FLEX Monoclonal Mouse Anti-Human CD20cy antibodies distributed nationwide in the United States. The recall cites weak staining that may yield false negative CD20 results. Labs and healthcare providers should stop using the product immediately and follow the manufacturer’s recall instructions.

Agilent Technologies Denmark
Their is
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Continu-Flo Intravascular Set Recalled for Tubing Separation — 14,400 Units in 2025

Baxter Healthcare Corporation issued an urgent medical device recall for one lot of Continu-Flo intravascular solution sets, 14,400 units distributed nationwide in the United States. Customer reports indicate tubing separation. Health care providers and patients should stop using the device immediately and follow recall instructions.

Baxter Healthcare
Baxter Healthcare
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Health & Personal Care
HIGH
FDA DEVICE

PHILIPS IntelliSpace Cardiovascular Software 8.0.0.4 Recall Affects 4 Units Nationwide

Philips Medical Systems Nederland B.V. recalls four IntelliSpace Cardiovascular software units distributed to facilities in Georgia, North Carolina and Texas. A software issue can display outdated information on the device. Hospitals should stop using the device immediately and follow Philips recall instructions.

Philips Medical Systems Nederland B.V.
Software issue
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Food & Beverages
HIGH
FDA FOOD

SUNGAL UDK Half Plum 170 g Recall for Cyclamate Adulteration (2025)

SUNGAL Inc. recalls 29 cases of UDK Half Plum, 170 g containers distributed to California, Maryland, New York and Virginia. The product is adulterated with cyclamate. Consumers should not consume it and should email SUNGAL Inc. for refund or replacement information.

SUNGAL
Cyclamate adulteration
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Health & Personal Care
HIGH
FDA DEVICE

Medline Medline Extremity Pack DYNJ45701B Sterile Kit Recall Affects 88 Units (2025)

Medline Industries recalled 88 units of the Sterile Extremity Pack DYNJ45701B after finding that kits labeled as sterile had not undergone sterilization. The affected distribution covered Florida, Maryland, New Jersey and Tennessee. Hospitals and clinics should stop using the kit immediately and follow Medline's recall instructions.

Medline Industries
Convenience kits
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Health & Personal Care
HIGH
FDA DEVICE

Medline Industries Recalls 22 Sterile Convenience Kits DYNJ0382730O, DYNJ61038B (2025)

Medline Industries, LP recalled 22 sterile convenience kits distributed to Florida, Maryland, New Jersey and Tennessee after determining the kits labeled as sterile had not undergone sterilization. The sterility lapse creates an infection risk for patients. Healthcare facilities and patients should stop using the kits and follow the recall instructions from Medline and the FDA.

Medline Industries
Convenience kits
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Tag Statistics

Total Recalls
1,260

Related Tags

electrical hazardimmediate actionstop use immediatelyreplacement availableadult productelderly productwinter productoutdoorelectronicbattery poweredmandatory standard violationcpsc regulated