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

3751–3775 of 13512

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-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-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-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-1233-2025·2025-03-05
Clinical Chemistry Analyzer Fails to Track Assay Expiration Dates After Software Update
A software issue in the DxC 500 AU analyzer prevents correct tracking of assay expiration dates after software upgrades. Expired assays may be used, potentially producing inaccurate patient test results.
Product
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Category
Medical Device
Distribution
19 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-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-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-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-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
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-1232-2025·2025-03-05
LIFEPAK 20e Defibrillator Recalled for Incorrect Keypad Installation
Physio-Control is recalling LIFEPAK 20e defibrillator/monitor units distributed in West Virginia due to incorrect keypad installation during manufacturing. The keypad error may affect device operation.
Product
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Category
Medical Device
Distribution
1 state
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-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-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-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-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-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-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-1206-2025·2025-03-05
BD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.
Product
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2025·2025-03-05
BD PYXIS MEDBANK systems operating room contraindication labeling update
BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.
Product
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1229-2025·2025-03-05
BD PYXIS medication cabinets labeling update: operating room contraindication
CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.
Product
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1228-2025·2025-03-05
BD PYXIS MEDBANK Medication Systems: Labeling Update for Operating Room Restriction
CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.
Product
155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1248-2025·2025-03-05
Medical device recall: sterilization validator with incorrect incubation time
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
Product
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1144-2025·2025-02-26
Allura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk
Philips recalls Allura Xper FD20 fluoroscopy patient tables due to a mattress issue that may cause patients to fall during procedures.
Product
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Category
Medical Device
Distribution
Distributed nationwide

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3751–3775 of 13512