Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

8051–8075 of 89535

HighFDA (Devices)·Z-1236-2025·2025-03-05
Video Colonoscope May Cause Thermal Burns to Tissue During Use
The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.
Product
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1211-2025·2025-03-05
Tyber Medical recalls A.L.P.S. mvX Anatomic Lateral Fibula Plates due to screw malposition
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the locking hole during surgery, causing surgical delays.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0247-2025·2025-03-05
ViaMed Alcohol Prep Pads Recalled Due to Sterility and Manufacturing Issues
Rece International Corp. is recalling ViaMed Alcohol Prep Pads due to lack of sterility assurance and manufacturing process deviations. The affected product was distributed in Florida.
Product
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, N
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1217-2025·2025-03-05
Orthopedic Plate Locking Screw May Pass Through Hole During Surgery
Tyber Medical is recalling A.L.P.S. mvX-P Anatomic Lateral Fibula Plates because the locking screw may pass through the locking hole during surgery, causing surgical delays.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1247-2025·2025-03-05
Leica Biosystems Cryostat CM1950 Firmware Update May Cause Tissue Loss
A software issue in the Leica Biosystems CM1950 cryostat firmware update could result in loss of patient tissue. Serial numbers 12835 and 12854 are affected.
Product
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1221-2025·2025-03-05
Medial Tibia Plate Recall: Locking Screw Defect During Surgery
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may not properly secure during surgery, causing surgical delays. No injuries have been reported.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0583-2025·2025-03-05
Rajbhog Sweets Jelebi Jaggery recalled due to undeclared milk allergen
Rajbhog Distributors TX Inc. recalls Rajbhog Sweets Jelebi Jaggery for containing undeclared milk, an allergen that can trigger allergic reactions in sensitive consumers.
Product
Rajbhog Sweets Jelebi Jaggery, 9.5 oz packages and sold by weight from bulk trays.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1241-2025·2025-03-05
GE Healthcare MRI system recalled for RF energy safety control failure
GE Healthcare's Optima MR360 MRI systems may allow unsafe RF energy exposure if a scan resumes after power loss. The user interface can incorrectly enable scanning when tissue-heating levels exceed safe limits.
Product
Optima MR360, NMRI system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2025·2025-03-05
Orthopedic fibula plate locking screw failure during surgery
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to locking screw passing through the locking hole intra-operatively, causing surgical delays. The recall affects 397 units distributed nationwide.
Product
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2025·2025-03-05
BD Pyxis MedBank medication cabinets recalled for operating room contraindication labeling
CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.
Product
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2025·2025-03-05
Medical Imaging Software Bug Affects Diagnostic Calculations on Daylight Saving Time Dates
A software bug in IntelePACS causes incorrect diagnostic value calculations on Daylight Saving Time transition dates, risking incorrect patient diagnoses.
Product
IntelePACS (Image Fusion Module) - InteleViewer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1220-2025·2025-03-05
Medial tibia plate screw locking defect causes surgical delays
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may pass through the locking hole during surgery instead of securing properly, causing surgical delays. The recall affects 210 units distributed nationwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2025·2025-03-05
Orthopedic plate recall: locking screw may pass through hole during surgery
Tyber Medical is recalling 214 units of A.L.P.S. mvX orthopedic plates (nationwide) because the locking screw may pass through the locking hole during surgery. Surgical delays have been reported.
Product
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: 770708081
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0581-2025·2025-03-05
Rajbhog Sweets Jelebi Orange Recalled for Undeclared Milk Allergen
Rajbhog Sweets Jelebi Orange is being recalled due to undeclared milk. Consumers with milk allergies should not consume this product.
Product
Rajbhog Sweets Jelebi Orange, 9.5 oz packages and sold by weight from bulk trays.
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0248-2025·2025-03-05
Avastin intravitreal injection syringes recalled for sterility assurance failure
Turbare Manufacturing recalls 1,147 syringes of Avastin 1.25 mg intravitreal injection nationwide due to a quality control process deviation affecting sterility assurance.
Product
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0573-2025·2025-03-05
Idaho Pacific Potato Flour Recalled for Undeclared Milk Allergen
Idaho Pacific Fine Potato Flour has been recalled due to undeclared milk content (13-17 ppm) not listed on the label. Consumers with milk allergies should not consume this product.
Product
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.
Category
Food
Distribution
3 states
HighFDA (Food)·F-0575-2025·2025-03-05
Beverage Base Recalled for Undeclared Yellow #5 Allergen
OCBW INC is recalling Beverage Base Sweet&Sour in 3-gallon bulk containers due to undeclared Yellow #5, a color additive. The product was distributed across eight states and poses a risk to consumers with sensitivities to this ingredient.
Product
Beverage Base Sweet&Sour, 3 gallon, BIB: Best By 12/10/2025
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1226-2025·2025-03-05
Medial Tibia Plate Recall Due to Locking Screw Malfunction During Surgery
Tyber Medical recalls 109 units of the A.L.P.S. mvX Medial Tibia Plate nationwide due to reports of the locking screw passing through the locking hole during surgery, causing surgical delays.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0574-2025·2025-03-05
Beverage Base Lemonade Recalled for Undeclared Yellow #5
OCBW INC is recalling Beverage Base Lemonade products due to undeclared Yellow #5. A total of 8,847 units were distributed across eight states. Consumers with sensitivities to food dyes should not consume the product.
Product
Beverage Base Lemonade, 3 gallon, BIB: Best By 12/12/2025; Beverage Base Lemonade, 5 gallon, BIB: Best By 01/12/2026
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1234-2025·2025-03-05
Socrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.
Product
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2025·2025-03-05
Pentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk
Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.
Product
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0246-2025·2025-03-05
Estradiol Gel Recalled Nationwide for Defective Packet Sealing
Padagis US LLC recalls Estradiol Gel 0.1% nationwide due to defective packets that may not be fully sealed, potentially allowing ethanol loss.
Product
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1237-2025·2025-03-05
PENTAX Medical Video Upper GI Endoscope Thermal Burn Risk Recall
Pentax of America is recalling 138 PENTAX Medical Video Upper GI Scopes due to a thermal injury risk. The light guide tip can become excessively hot during endoscopic procedures, potentially burning patient tissue.
Product
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0582-2025·2025-03-05
Rajbhog Sweets Jelebi Yellow Recalled for Undeclared Milk Allergen
Rajbhog Sweets Jelebi Yellow is recalled due to undeclared milk, a major allergen. The voluntary recall affects 531 lbs distributed in Texas.
Product
Rajbhog Sweets Jelebi Yellow, 9.5 oz packages and sold by weight from bulk trays.
Category
Food
Distribution
1 state
HighFDA (Food)·F-0576-2025·2025-03-05
Deiorio Foods Cauliflower Shells Recalled for Plastic Fragment Contamination
Deiorio Foods is recalling 1701 cases of 5912MOD-CAU 11" Gluten Free Friendly Cauliflower Shells due to potential contamination with white plastic fragments. The product may pose a choking hazard.
Product
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
Category
Food
Distribution
11 states

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8051–8075 of 89535