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 8,301–8,350 of 15,362

Medical Device Recall · January 27, 2025
Hiossen Inc.
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catal
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Class II
Medical Device Recall · January 27, 2025
Hiossen Inc.
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number:
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Class II
Medical Device Recall · January 27, 2025
Hiossen Inc.
ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number:
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Class II
Food Recall · January 25, 2025
Amazon Retail LLC
ASIN B084PZ7K98, Amazon Fresh Jumbo Sugar Cookie, 27 oz (12 count), product is baked and packaged in flexible plastic bag. 4-day shelf life. UPC 465712007998. ASIN B084PX9V31, Amazon Fresh Jumbo Suga
Undeclared egg.
Class I
Food Recall · January 25, 2025
Amazon Retail LLC
ASIN B0CY2RDW5T, Amazon Fresh brand, Bake at Home Jumbo Sugar Cookie 30oz, product is frozen dough, and packaged in flexible plastic bag. UPC 446472006995.
Undeclared egg.
Class I
Drug Recall · January 24, 2025
SKY PACKAGING
HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Pa
Failed Impurities/Degradation Specifications
Class II
Medical Device Recall · January 24, 2025
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Class II
Drug Recall · January 24, 2025
RemedyRepack Inc.
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II
Food Recall · January 24, 2025
Deiorio Foods Inc
5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shell; Bulk packaged in a blue poly bag, within a corrugated box. 20 units per case; Product UPC: 074542659125; Master Case GTIN: 00074542659125
Product may be contaminated with foreign objects (white fragments of plastic, varying in length and width).
Class II
Drug Recall · January 24, 2025
SKY PACKAGING
HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN
Failed Impurities/Degradation Specifications
Class II
Medical Device Recall · January 24, 2025
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated N
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Class II
Consumer Product Recall · January 23, 2025
GiantMouse LLC, of East Lansing, Michigan
GM12 and GMP12 Folding Knives
The locking mechanism on the folding knives can fail, posing a laceration hazard to the user.
Unclassified
Food Recall · January 23, 2025
Bridgewell Agribusiness LLC
5912MOD-CAU Pre-Blend, item #991819, is a dry blend. Ingredients consist of Tapioca Starch, Long Grain Rice Flour, Cheese Powder [Cheddar Cheese (Cultured Pasteurized Milk, Salt, Enzymes), Disodium Ph
Foreign material appears to be white nylon or other plastic thread was found in product.
Class II
Consumer Product Recall · January 23, 2025
CLSYS International Inc., of New York
NQDTPBOR Multi-Purpose Helmets
The helmets do not comply with the positional stability, impact, labeling and certification requirements of the mandatory federal safety regulation for bicycle helmets. The helmets can fail to protect the wearer in the event of a crash, posing a risk of head injury.
Unclassified
Drug Recall · January 23, 2025
FDC Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jerse
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II
Medical Device Recall · January 23, 2025
CareFusion 303, Inc.
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, p
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
Class II
Medical Device Recall · January 23, 2025
CareFusion 303, Inc.
BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies
Due to fingerprint scanner failing resulting in the scanner heating up.
Class II
Medical Device Recall · January 23, 2025
LUMENIS, LTD.
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.
Class II
Consumer Product Recall · January 23, 2025
SHEIN Distribution Corporation, of Los Angeles, California
Teckwe Hair Dryer Brushes
The handheld hair dryer brushes lack an immersion protection device, posing an electrocution or shock hazard to consumers if the hair dryer brushes fall into water when plugged in. The CPSC has determined that hair dryers not equipped with the integral immersion protection present a substantial product hazard.
Unclassified
Consumer Product Recall · January 23, 2025
Duluth Holdings Inc., dba Duluth Trading Company, of Mt. Horeb, Wisconsin
Children's Holiday Pajama Sets
The recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
Unclassified
Consumer Product Recall · January 23, 2025
Shaoxingkeqiao Nenghaozhenfang Co. Ltd., of China
ChrisDowa Roller Window Shades
The recalled roller shades have long operating cords that pose strangulation and entanglement hazards to children, in violation of the federal regulations for window coverings. The shades also violate labeling requirements for window coverings.
Unclassified
Drug Recall · January 22, 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II
Drug Recall · January 22, 2025
Glenmark Pharmaceuticals Inc., USA
Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II
Food Recall · January 22, 2025
La Fiesta Food Products
La Fiesta PAN RAYADO SAZONADO Bread Crumbs Seasoned, NET WT 8 OZ. (227g), UPC# 032327000887
Firm distributed a Seasoned Bread Crumb product with undeclared allergen (Sesame) not on the label.
Class I
Food Recall · January 22, 2025
La Fiesta Food Products
La Fiesta PAN RAYADO Bread Crumbs, NET WT 8 OZ. (227g), UPC# 032327000886
Firm distributed a Bread Crumb product with undeclared allergen (Sesame) not on the label.
Class I
Drug Recall · January 21, 2025
AvKARE
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Out of Specification for Dissolution
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101
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 21, 2025
Tyber Medical
A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121
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 21, 2025
Tyber Medical
A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia
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 21, 2025
Physio-Control, Inc.
LIFEPAK 35 ECG cable REF 11111-000041
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Class II
Drug Recall · January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102
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 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
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
Food Recall · January 21, 2025
D. Coluccio & Sons Inc.
COLUSSI CANTUCCINI CHOCOLATE DROPS COOKIES
Contains undeclared visible almonds
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121
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 21, 2025
Tyber Medical
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041
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 21, 2025
Tyber Medical
A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715161
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 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description
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
Drug Recall · January 21, 2025
Provepharm Inc.
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426
Presence of Particulate Matter.
Class I
Drug Recall · January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and D
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Medical Device Recall · January 21, 2025
Physio-Control, Inc.
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 119
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061
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 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
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 21, 2025
Tyber Medical
A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715162
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 21, 2025
Tyber Medical
A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
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 21, 2025
Tyber Medical
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061
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
Drug Recall · January 21, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and D
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II
Medical Device Recall · January 21, 2025
Tyber Medical
A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770708101
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 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 77070808
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 21, 2025
Tyber Medical
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Descripti
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