fda regulated Recalls

689 recalls tagged with “fda regulated”.

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
HIGH
FDA DEVICE

Medline Recalls Dialysis Dressing Change Kits Over High Hazard

Medline Industries recalled 31,848 dialysis dressing change kits on January 8, 2026. The recall follows reports of defective silicone seals on Tego Connectors that may occlude fluid paths. This defect can delay therapy and expose patients to biological contaminants.

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

Medline Recalls Convenience Kits Over Sterility Concerns

Medline recalled 27,320 convenience kits on January 7, 2026, due to calibration issues with sterilization equipment. These defects may compromise the sterility assurance level of the products. Healthcare providers and patients should stop using the affected kits immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Potential Deformity Hazard

Olympus Corporation of the Americas recalled 3,954 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall occurred due to devices that may not have undergone proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients should stop using the devices immediately and follow the recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Surgical Kits Over Sterility Concerns

Medline Industries recalled 12,418 surgical kits on January 7, 2026, after identifying calibration issues in sterilization equipment. The defects could compromise sterility assurance levels of the devices. Healthcare providers and patients must stop using the affected products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Surgical Kits Recalled Over Sterilization Issues

Medline Industries recalled 4,415 surgical kits on January 7, 2026, due to sterilization calibration issues. These issues could compromise the sterility assurance level of the products. Healthcare providers and patients must stop using the kits immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Convenience Kits Recalled Due to Sterility Concerns

Medline Industries recalled 7,725 surgical kits on January 7, 2026, due to potential sterility issues. Calibration problems with sterilization equipment may compromise the sterility assurance level. Healthcare providers and patients should stop using these kits immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Burn Care Kits Due to Sterility Issues

Medline Industries recalled 291 units of burn care kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Users should stop using the affected products immediately.

Medline Industries, LP
Medline has
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Food & Beverages
HIGH
FDA FOOD

Karison Foods Recalls Panjiri Due to Undeclared Milk Ingredient

Karison Foods & Snacks Inc. recalled 2,760 units of its Panjiri snack on January 6, 2026. The product contains milk, which is not declared on the label. This recall affects consumers in New York, New Jersey, and Virginia.

Karison Foods & Snacks
Product contains
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Food & Beverages
HIGH
FDA FOOD

Carrot Top Kitchens Hummus Recalled for Undeclared Sesame

Carrot Top Kitchens recalled 12 units of Lemon & Garlic Hummus on January 6, 2026. The product contains undeclared sesame, posing a serious allergy risk. Consumers should stop use and seek a refund or replacement immediately.

Carrot Top Kitchens
Contains undeclared
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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 DEVICE

Encore Medical Recalls EMPOWR Acetabular System Over Packaging Errors

Encore Medical, LP recalled 49 units of the EMPOWR Acetabular System on January 5, 2026. Packaging errors may cause surgical delays, potentially affecting patient safety. Healthcare providers should stop using these devices immediately.

Encore Medical, LP
942-01-40G acetabular
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Health & Personal Care
HIGH
FDA DEVICE

AVID Medical Recalls Transport Bag Kit Over Sterility Risk

AVID Medical recalled 1,500 units of the TRANSPORT BAG KIT on January 2, 2026. A seal issue with the Tyvek bag may compromise the sterility of the kit. The recall affects healthcare providers and patients in New Jersey.

AVID Medical
Tyvek bag
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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

Sun Pharmaceutical Fluocinolone Acetonide Topical Solution Recall 24,624 Bottles (2025)

Sun Pharmaceutical Industries is recalling 24,624 bottles of Fluocinolone Acetonide Topical Solution nationwide after out-of-spec impurity D was detected. The product is distributed by Taro Pharmaceuticals in the United States and labeled Rx-only. Consumers must stop using the product and consult a healthcare provider for guidance.

Fluocinolone Acetonide
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Ice Gel 8oz 12-Count Recalled for CGMP Violations (2026)

Gold Star Distribution recalls 8oz Ice Gel 12-count sold nationwide after investigators found insanitary conditions at the distributor's facility. A CGMP deviation allowed rodent exposure at the distribution center. Consumers and healthcare providers should stop using this product immediately and await guidance from Gold Star Distribution.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

GOLD STAR DISTRIBUTION Vaporizing Chest Rub Recall 2026 All Lots Nationwide

Gold Star Distribution is recalling all lots of its Vaporizing Chest Rub, 4 oz, 12-count, UPC 048155903319, distributed nationwide in the United States. The recall, number D-0283-2026, stems from CGMP deviations including insanitary conditions with rodent exposure/activity at the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Gold Star Distribution Recalls Feminine Hygiene Products Due to Rodent Exposure

Gold Star Distribution recalled various feminine hygiene products on December 26, 2025. The recall affects brands including KOTEX and ALWAYS due to potential rodent contamination in their distribution center. Consumers should stop using these products immediately and follow manufacturer instructions for return.

GOLD STAR DISTRIBUTION
Potential exposure
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Excedrin Migraine 2's 25 CT Over Rodent-Contamination Risk (2026)

Gold Star Distribution recalls Excedrin Migraine 2's, 25-count bottles distributed nationwide in the United States. CGMP deviations involve insanitary conditions including rodent exposure in the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution or their healthcare provider for guidance.

Gold Star Distribution
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Gold Star Distribution Recalls Pepto Bismol 32-Count in 2025 Over CGMP Sanitation Violations

Gold Star Distribution is recalling Pepto Bismol 32-count distributed nationwide after CGMP deviations and unsanitary conditions at its distribution center. The recall cites rodent exposure and unsanitary distribution practices. Consumers and healthcare providers should stop using this product immediately and contact Gold Star Distribution for guidance.

Gold Star Distribution
CGMP Deviations:
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Tag Statistics

Total Recalls
689

Related Tags

electrical hazardimmediate actionstop use immediatelyreplacement availablecpsc regulatedelectronicmetallithium batteryinfant productadult productworkplacerepair available