fda regulated Recalls

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

Medline Recalls Dialysis Dressing Change Kits Over High Hazard

Olympus Recalls Sphincterotome Due to Potential Deformity Hazard

Devices which did not undergo thermoforming could deform and lose performance.

Medline Recalls Surgical Kits Over Sterility Concerns

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 Convenience Kits Recalled Due to Sterility Concerns

Medline Recalls Convenience Kits Over Sterility Concerns

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.

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

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.

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.

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.

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

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

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

Aleve 60-Count Pain Relievers Recalled for CGMP Deviations by Gold Star Distribution (2026)

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

GOLD STAR DISTRIBUTION TUMS 12-Count Recall 2026 for Rodent-Contamination CGMP Deviations

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

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

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

Lucky Ice Cool Mouthwash Recall 2026 After CGMP Deviations at Gold Star Distribution

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.