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

4451–4475 of 39987

HighFDA (Devices)·Z-1231-2025·2025-03-05
Infusion Pump Manual Instructs Users to Leave Safety Clamp Open
BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.
Product
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, pediatric, and neonatal patients through clinically accepted routes of administra
Category
Medical Device
Distribution
51 states
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-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 (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 (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-1218-2025·2025-03-05
Orthopedic Fixation Plates Recalled for Screw Locking Failure During Surgery
Tyber Medical is recalling 115 A.L.P.S. mvX orthopedic plates because the locking screw can pass through the locking hole during surgery, causing surgical delays and inadequate fracture fixation.
Product
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 Description:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1242-2025·2025-03-05
MRI Systems May Resume Scans When SAR Exceeds Safe Limits
Certain GE Healthcare MRI systems may incorrectly enable scan resumption when radiofrequency energy absorption exceeds FDA-set limits, potentially causing tissue heating. Risk is higher for patients with implants or touching conductive materials.
Product
SIGNA MR355, SIGNA MR360, NMRI system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2025·2025-03-05
A.L.P.S. mvX Medial Tibia Plate Locking Screw Malfunction Recall
Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1212-2025·2025-03-05
A.L.P.S. mvX Fibula Plate Recall: Locking Screw Malfunction During Surgery
Tyber Medical is recalling 408 units of the A.L.P.S. mvX Anatomic Lateral Fibula Plate because the locking screw can pass through the locking hole during surgery, causing surgical delays. No injuries have been reported.
Product
A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1240-2025·2025-03-05
MRI System May Resume Scanning Above Safe Thermal Limits
GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.
Product
Brivo MR355, NMRI system
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 (Devices)·Z-1209-2025·2025-03-05
Anatomic Lateral Fibula Plate recalled for locking screw malfunction
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates due to reports of locking screws passing through the locking hole during surgery, causing surgical delays.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
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 (Devices)·Z-1239-2025·2025-03-05
MRI Systems Allow Unsafe Scan Resumption Exceeding SAR Safety Limits
GE Healthcare MRI systems may incorrectly resume scans after power loss when tissue heating rates exceed safe limits, risking excessive heating if patients contact conductive materials or have implants.
Product
SIGNA Creator, SIGNA Explorer, NMRI systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1215-2025·2025-03-05
Anatomic Lateral Fibula Plate locking screw malfunction during surgery
Tyber Medical is recalling 220 A.L.P.S. mvX Anatomic Lateral Fibula Plates due to complaints that the locking screw passes through the locking hole during surgery, causing surgical delays.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2025·2025-03-05
Orthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall
Tyber Medical is recalling 209 A.L.P.S. mvX Medial Tibia plates nationwide due to reports that locking screws can pass through the locking hole during surgery, causing surgical delays.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1216-2025·2025-03-05
Anatomic lateral fibula plate locking screw failure during surgery
Tyber Medical A.L.P.S. mvX anatomic lateral fibula plates (219 units nationwide) have a defect where the locking screw can pass through its locking hole during surgery, causing surgical delays.
Product
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:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1243-2025·2025-03-05
GE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption
GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.
Product
SIGNA MR380, NMRI system, Non-US Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1223-2025·2025-03-05
FDA Recalls Medial Tibia Plates for Intra-operative Screw Failure
Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates due to reports that the locking screw can pass through the locking hole during surgery, causing surgical delays.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1235-2025·2025-03-05
Plato 17 Microcatheter Recall Due to Sterile Barrier Packaging Defect
Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.
Product
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 interventional or diagnostic procedures.
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-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-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-1225-2025·2025-03-05
Medical plate locking screw may fail during fracture surgery
A locking screw in the A.L.P.S. mvX Medial Tibia Plate may pass through its locking hole during surgery. Surgical delays have been reported with this device.
Product
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
Category
Medical Device
Distribution
Distributed nationwide

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4451–4475 of 39987