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

3726–3750 of 13512

ModerateFDA (Devices)·Z-1273-2025·2025-03-12
Dental Abutments Recalled for Incorrect Version Identification Stickers
Hiossen Inc. is recalling ET Rigid Abutments due to incorrect patient chart stickers that misidentify product versions. The stickers may label Mini abutments as Regular or identify other abutment models incorrectly, risking use of the wrong component.
Product
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/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: ETRGA4544MP
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1271-2025·2025-03-12
Dental implant abutments recalled for incorrect packaging labels
Hiossen has recalled ET Rigid Abutment dental implant components because stickers in the packaging mislabel whether products are Mini or Regular versions. Incorrect identification could affect proper implant installation.
Product
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/Catalog Number: ETRGA4515MP
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1290-2025·2025-03-12
Lumenis Pulse 120H Laser System Charger May Prevent Device Startup
Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.
Product
(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.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1252-2025·2025-03-12
Philips IntelliSpace Cardiovascular Software Data Archival Failure Recall
Philips cardiovascular diagnostic software version 7.0.0.0 cannot archive, copy, or export study data, affecting 139 units distributed nationwide. Users may experience data management and workflow disruptions.
Product
Philips IntelliSpace Cardiovascular software, Model 830089.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1251-2025·2025-03-12
Infiltration Cannula Recalled Due to Incorrect Water Jet Pattern
HUMAN MED AG is recalling 775 Biofill Infiltration Cannulas because the water jet may emerge as a spot jet rather than the specified fan-shaped spray pattern, affecting device functionality.
Product
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1272-2025·2025-03-12
Dental abutment implants recalled for incorrect patient chart stickers
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to patient chart stickers that incorrectly identify the product version. The stickers may identify Mini versions as Regular, or Multi-versions as Mini.
Product
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: ETRGA4537MP
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1292-2025·2025-03-12
Vios bedside monitor batteries may deplete during storage
Murata Vios bedside monitors may experience battery depletion if stored without power, causing tablet connectivity issues. Affected units should be kept plugged in while in storage.
Product
Vios Monitoring System Bedside Monitor Model BSM2050
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1296-2025·2025-03-12
BD BBL TB Stain Kit Expiration Date Labeling Discrepancy
BD BBL TB Stain Kit component shipped with incorrect expiration date labeling. One component has printed expiration 30 September 2024 while Certificate of Analysis indicates 30 April 2025, creating confusion about product validity.
Product
BD BBL TB Stain Kit K, Catalog (REF): 212522
Category
Medical Device
Distribution
14 states
SevereFDA (Devices)·Z-1196-2025·2025-03-05
Ventec VOCSN Ventilators Recalled Due to Incorrect Service Parts
Ventec Life Systems recalled VOCSN Multi-Function Ventilators (30 units in CA, NY, MO) due to incorrect parts used during service. Defects may cause unexpected shutdown or impaired respiratory monitoring and support.
Product
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Category
Medical Device
Distribution
3 states
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-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 (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-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-1207-2025·2025-03-05
Automated Medication Cabinet Recalled Due to Fingerprint Scanner Overheating Risk
CareFusion's BD Pyxis MedFlex automated medication cabinet is being recalled due to fingerprint scanner failure and overheating, posing a potential fire hazard in clinical settings.
Product
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 to a qualified and authorized user in a clinical setting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1219-2025·2025-03-05
Orthopedic tibia plate locking screw failure causes surgical delays
Tyber Medical recalls A.L.P.S. mvX Medial Tibia plates; the locking screw can pass through the locking hole during surgery, causing surgical delays.
Product
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
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-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-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-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-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-1214-2025·2025-03-05
Orthopedic Surgical Plates Recalled Due to Intra-Operative Locking Screw Malfunction
Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates nationwide due to reports that locking screws may pass through the locking hole during surgery, causing surgical delays.
Product
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
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-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

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3726–3750 of 13512