Safety Recalls

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15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 8,351–8,400 of 15,362

Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Class II
Medical Device Recall · January 20, 2025
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
Class II
Medical Device Recall · January 20, 2025
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
Class II
Food Recall · January 19, 2025
Arizona Foods Group, Inc.
FOOD SERVICE - Mombo s Vanilla Soft Serve Ice Cream Mix, frozen & thawed for Ice cream machines. Packaged in a half gallon carton 64 oz and placed in cases of 6-units. Shelf-life is 18 months froz
Product may contain egg, an undeclared allergen.
Class I
Food Recall · January 18, 2025
Idaho Pacific Corporation
Idaho Pacific Fine Potato Flour, product #20501, packaged in multi-walled Kraft bag, Net Wt. 50lbs. No UPC code. Manufactured by Idaho Pacific Corporation, Ririe, ID 83443.
Potato flour item #20501 was recalled due to undeclared milk (between 13ppm and 17ppm).
Class II
Food Recall · January 17, 2025
PIU CHE DOLCI INC.
Sweet Cream Mini Patisseries, 30 piece variety tray of mini pastries, Net Wt 1 kg, 4 trays per master carton, total Net wt 8.8 lbs, Keep Frozen, All best before dates from 2025/06/17 up to and includi
Due to potential Salmonella contamination
Class I
Medical Device Recall · January 17, 2025
Zhejiang Luyao Electronics Technology Co., Ltd.
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Mass
Regulatory documentation error and misleading color packaging claim.
Class II
Food Recall · January 17, 2025
Health and Happiness (H&H) LLC.
Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummies), Flexible Sachet packaging, Sample size package (4 Count), EXP: JUL/2025 Lot : 2413352PSF
Due to foreign object: metal balls (tiny non-magnetic metal balls measuring less than 2mm inside the gummies) intended for children
Class II
Drug Recall · January 17, 2025
McKesson
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class II
Drug Recall · January 17, 2025
The W.S. Badger Company, Inc.
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Class III
Medical Device Recall · January 17, 2025
KCI USA, INC.
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Ship
Due to increase in complaints related to leak alarms
Class II
Medical Device Recall · January 17, 2025
KCI USA, INC.
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena
Due to increase in complaints related to leak alarms
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Servic
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B,
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Consumer Product Recall · January 16, 2025
Polaris Industries Inc., of Medina, Minnesota
Model Year 2024-2025 Ranger XD 1500 and Crew XD 1500 ROVs
The door handle can stick and cause the door to unexpectedly open while the vehicle is moving and cause an unrestrained rider to be ejected from the vehicle or increase the risk of a crash, posing serious injury and crash hazards.
Unclassified
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Servi
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
Spectrum Medical Inc
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version:
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Class II
Consumer Product Recall · January 16, 2025
Lexmark International Inc., of Lexington, Kentucky
MS725dvn and MX725adve Specialty Printers
A metal part inside the printer can dislodge, posing a risk of fire.
Unclassified
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1,
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
Scientia Vascular, Inc.
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during inte
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Serv
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Consumer Product Recall · January 16, 2025
Ivy City Co., of Riverton, Utah
Mini Bella Bunny Pajamas, Mini Camille Pajamas and Mini Petra Nightgown
The recalled children's pajamas violate the flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Unclassified
Food Recall · January 16, 2025
Wismettac Asian Foods, Inc.
Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Sea Salt & Umami Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD; Nutritional Facts: 2.5 servings per container; Distribute
Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Class I
Drug Recall · January 16, 2025
Appco Pharma LLC
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class III
Consumer Product Recall · January 16, 2025
Three61 LLC, of Palm Harbor, Florida
Samurai Mini Smoke Alarms
The smoke alarms can malfunction and fail to alert consumers of a fire, posing a risk of smoke inhalation or death. Smoke sensitivity tests performed on the alarms by CPSC found that one of the detectors that was tested failed to alert when exposed to pre-determined concentrations of smoke.
Unclassified
Consumer Product Recall · January 16, 2025
YKHallyBee, of China
HallyBee Farmhouse 5-Drawer Dressers
The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers do not comply with the performance requirements of the STURDY Act.
Unclassified
Food Recall · January 16, 2025
Wismettac Asian Foods, Inc.
Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Corn Potage Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD; Nutritional Facts: 2.5 servings per container; Distributed by
Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Class I
Food Recall · January 16, 2025
Wismettac Asian Foods, Inc.
Front Panel: Shirakiku brand, CURVEE PUFFS CORN PUFF SNACK, Curry Flavor, NET WT 2.46 oz (70 g); Rear panel:Best Before YYYY.MM.DD; Nutritional Facts: 2.5 servings per container; Distributed by Wismet
Undeclared allergen (Milk) in Shirakiku brand Curvee Puffs Corn Puff Snack
Class I
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Medical Device Recall · January 16, 2025
RAYSEARCH LABORATORIES AB
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Class II
Consumer Product Recall · January 16, 2025
Northern Tool + Equipment Company Inc., of Burnsville, Minnesota
Northern Tool + Equipment Adjustable Swivel Shop Stools with Backrests
The welded connection point between the seat base and the stool post can break, presenting a fall hazard.
Unclassified
Consumer Product Recall · January 16, 2025
Vornado Air LLC, of Andover, Kansas
VH2 Whole Room Heaters
The power cord can partially detach from the heater enclosure, which can lead to cord damage over time, posing electric shock and fire hazards.
Unclassified
Consumer Product Recall · January 16, 2025
Veyer LLC, of Boca Raton, Florida
WorkPro® Momentum Office Chairs
The bolts that connect the back of the chair to its base can fail, posing a fall hazard to users.
Unclassified
Medical Device Recall · January 15, 2025
Hologic, Inc
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Class II
Food Recall · January 15, 2025
The Candy Basket Inc
Raspberry Jelly Sticks MILK, item number CB747-M, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases f
Undeclared Red #40 and Potassium Sorbate.
Class III
Food Recall · January 15, 2025
The Candy Basket Inc
Raspberry Jelly Sticks DARK, Item Number CB747-D, packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from
Undeclared Red #40 and Potassium Sorbate
Class III
Medical Device Recall · January 15, 2025
Olympus Corporation of the Americas
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush;
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Class I
Medical Device Recall · January 15, 2025
Philips North America Llc
IntelliBridge EC10 Module. Model Number: 865115
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II
Food Recall · January 15, 2025
The Candy Basket Inc
Orange Jelly Sticks MILK, item number CB741-M, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from
Undeclared Yellow #6, and Sodium Benzoate.
Class II
Medical Device Recall · January 15, 2025
TERRAGENE S.A.
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Class II
Food Recall · January 15, 2025
The Candy Basket Inc
Orange Jelly Sticks DARK, item number CB741-D, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from
Undeclared Yellow #6, and Sodium Benzoate.
Class II
Food Recall · January 15, 2025
The Candy Basket Inc
Lemon Jelly Sticks WHITE, item number CB750-W, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases from
Undeclared Yellow #5 and Potassium Sorbate.
Class II
Food Recall · January 15, 2025
The Candy Basket Inc
Marionberry Jelly Sticks DARK, item number CB745-D, is packed and sold in bulk 4lbs. boxes. Product does not have a UPC and is not repackaged for retail. Product was sold out of bulk chocolate cases
Undeclared Red #3, Blue #1, Potassium Sorbate, and Propylene Glycol.
Class III
Food Recall · January 15, 2025
AKT Trading Inc.
Menma Ajitsuke prepared bamboo shoots; Product of Japan; Manufactured by: Choshiya Honten CO., LTD. Hamamatsu 431-1103 Japan UPC 4 923673 527332. Product is packaged in 8.8 OZ Plastic Pouches. 60 un
CHOSHIYA branded MENMA AJITSUKE PREPARED BAMBOO SHOOTS missing "Keep Refrigerated" statement on package and are not shelf stable.
Class I
Food Recall · January 15, 2025
Robin J Vos dba TS Food Packaging
Bacon flavored Popcorn Seasoning packaged under the following brands and sizes: 1. Wabash Valley Farms, Net Wt. 4.2 oz (119.1g), UPC 0 19669-00303 1. Dist. by: Wabash Valley Farms, Monon, IN 479
Undeclared allergen (soy).
Class II
Medical Device Recall · January 15, 2025
Philips North America Llc
IntelliVue Patient Monitor MX550. Model Number: 866066
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Class II