replacement available Recalls

280 recalls tagged with “replacement available”.

Health & Personal Care
HIGH
FDA DEVICE

Olympus ShockPulse-SE Lithotripsy System Recall Expands to 55 Units in 5 Countries (2026)

Olympus Corp. of the Americas recalls 55 ShockPulse-SE Lithotripsy System units distributed internationally. Mis-wired component may create noise on the power supply and ultrasonic circuit. Hospitals and providers should stop using the device immediately and follow recall instructions. Notify Olympus or your healthcare provider for guidance.

Olympus
Mis-wired component-the
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Health & Personal Care
LOW
FDA DRUG

Encon Safety Products Recalls AQ 120 GFEW Aquarion Preserved Cartridges in 2026

Encon Safety Products recalls AQ 120 GFEW Aquarion Preserved Cartridges sold nationwide through multiple retailers. The recall cites cGMP deviations in manufacturing. Stop using the product immediately and follow recall guidance from Encon Safety or your healthcare provider.

Encon Safety Products
cGMP deviations.
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Health & Personal Care
HIGH
FDA DRUG

Cipla Lanreotide Acetate Injection Recall: 15,221 Syringes Over Particulate Matter (2026)

Cipla USA, Inc. is recalling 15,221 Lanreotide Acetate Injection syringes nationwide in the United States after detecting particulate matter. The defect is the presence of particulate matter in the injectable solution. Healthcare providers and patients should stop using the product immediately and contact Cipla USA for guidance.

LANREOTIDE ACETATE
Presence of
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls EXCEDRIN 2'S DISP.- 30 CT in 2026 Recall

Gold Star Distribution recalls EXCEDRIN 2'S DISP.- 30 CT distributed nationwide in the United States. The recall cites CGMP deviations due to insanitary conditions including rodent exposure at the distribution center. Consumers and healthcare providers should stop using the product immediately and await guidance from Gold Star Distribution.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Colgate and Crest Toothpaste Recall 2025 by Gold Star Distribution for CGMP Deviations

Gold Star Distribution Inc. issued a nationwide recall of Colgate and Crest toothpaste on December 26, 2025 after inspectors found insanitary conditions and rodent exposure at its distribution center. The issue stems from CGMP deviations that could contaminate products. Consumers should stop using the affected toothpaste immediately and contact Gold Star Distribution for guidance.

Colgate
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Tylenol Recall by Gold Star Distribution Affects 5 SKUs in 2026

Gold Star Distribution is recalling Tylenol products distributed nationwide. The recall concerns CGMP deviations and insanitary conditions at the distributor’s facility. Consumers should stop using these Tylenol products immediately and contact Gold Star Distribution for guidance.

Gold Star Distribution
CGMP Deviations:
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Food & Beverages
HIGH
FDA DRUG

Swan White Clear Alcohol Recall by Gold Star Distribution in 2026

Gold Star Distribution recalls Swan White Clear Alcohol, 50% ABV, 16 oz, 12 count, nationwide. FDA enforcement cites CGMP deviations and insanitary distribution-center conditions including rodent exposure. Stop using the product now and contact the distributor or a healthcare provider for guidance.

Swan
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Carmex Lip Balm Recalled by Gold Star Distribution for 12-Count Jars and Tubes (2026)

Gold Star Distribution Inc. is recalling Carmex lip balm in 12-count jars and 12-count tubes distributed nationwide in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.

GOLD STAR DISTRIBUTION
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Vascutek Gelsoft Plus and Gelweave Vascular Prostheses Recalled for Shelf-Life Label Error (37,430,

Vascutek recalled 37,430 Gelsoft Plus and Gelweave vascular prostheses distributed nationwide in the United States after discovering the devices were labeled with an extra month of shelf life. The expiry date was calculated from packaging rather than gel impregnation. Healthcare providers and patients should stop using the devices immediately and follow recall instructions.

Vascutek
Gelatin sealed
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Food & Beverages
HIGH
FDA FOOD

Prima Vera Nueva Recalls Tamales Due to Listeria Risk

Prima Vera Nueva recalled 16,790 packages of Black Bean Bonanza Tamales on December 12, 2025. The company cited potential contamination with Listeria monocytogenes, a serious foodborne pathogen. Consumers should not eat these tamales and should seek a refund or replacement.

Prima Vera Nueva
Potential contamination
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si Monopolar Curved Scissors Recall for 86,904 Units Worldwide (2025)

Intuitive Surgical recalled 86,904 da Vinci S and Si Monopolar Curved Scissors instruments sold worldwide to hospitals and surgical centers. The recall cites increased complaints of broken or frayed grip cables on reusable instruments. Healthcare facilities should stop using the device immediately and follow the manufacturer’s recall instructions.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S, Si Grasping Retractor Instrument Recalled for 2,660 Units (2026)

Intuitive Surgical recalled 2,660 da Vinci S/Si Grasping Retractor Instruments worldwide after increased complaints of broken or frayed grip cables. The devices transmit motion from input disks to the distal tip and are used in robotic surgery. Hospitals and surgical centers should stop using the device immediately and follow recall instructions from the manufacturer.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si EndoWrist Recall 6,152 Instruments for Pitch Cable Frays (2026)

Intuitive Surgical recalled 6,152 da Vinci S, Si Permanent Cautery Hook Instruments distributed to U.S. hospitals and clinics overseas. The defect involves frayed or broken pitch cables. Healthcare facilities should stop using the instruments immediately and follow manufacturer recall instructions. If you operate with these tools, consult your supplier or Intuitive Surgical for next steps.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls 2,095 da Vinci S, Si EndoWrist Tenaculum Forceps Instrument (2025)

Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si Mega Needle Driver Instrument Recall 7,819 Units Worldwide (2026)

Intuitive Surgical recalled 7,819 units of the da Vinci S/Si Mega Needle Driver Instrument sold worldwide to hospitals and healthcare providers. The recall cites broken or frayed grip cables that can impair instrument control. Stop using the device and follow the manufacturer’s recall instructions for replacement or service.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Zimmer Recalls Affixus Antegrade Femoral Nails Over Fracture Risk

Zimmer Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, leading to potential health risks. Patients should stop using the devices immediately and contact their healthcare provider.

Zimmer
Affected implants
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Health & Personal Care
HIGH
FDA DEVICE

Zimmer Recalls Affixus Femoral Nails Over Fatigue Fracture Risk

Zimmer, Inc. recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. These implants may have an undersized distal diameter that could lead to fatigue fractures. Patients should stop using the device immediately and contact their healthcare provider.

Zimmer
Affected implants
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Food & Beverages
HIGH
FDA FOOD

Face Rock Creamery Garlic Cheddar Cheese Recalled for Listeria Risk

Face Rock Creamery recalled 16 units of Vampire Slayer Garlic Cheddar cheese on November 14, 2025. The recall follows the discovery of Listeria monocytogenes in the processing area. Consumers should not consume the product and seek a refund or replacement.

FRC
FDA environmental
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