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

3651–3675 of 13449

HighFDA (Devices)·Z-1250-2025·2025-03-12
TBS iNsight bone density software calculation variability on Hologic machines
TBS iNsight medical device software may produce inconsistent calculation results when operating on Hologic Horizon bone densitometers, particularly when comparing fast array scans to standard array scans.
Product
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitom
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-1268-2025·2025-03-12
Heat Moisture Exchanger Connector Occlusion May Impair Ventilation
Kung Shin Plastics' CircuitGuard ThermoFlo Filter may have plastic obstructing the machine-side connector, preventing proper ventilation bag operation and risking oxygen deprivation during manual ventilation.
Product
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1255-2025·2025-03-12
Medtronic Paradigm insulin pumps may deliver incorrect doses during flight
Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.
Product
Paradigm REF: MMT-712 and MMT-715
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1293-2025·2025-03-12
Alcon Custom Pak surgical packs mislabeled as latex-free despite containing latex
Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.
Product
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1265-2025·2025-03-12
MiniMed Insulin Pump May Malfunction at High Altitude During Flight
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during airplane takeoff or landing due to air pressure changes, potentially causing severe low or high blood sugar.
Product
MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2025·2025-03-12
Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Product
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2025·2025-03-12
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during flight
Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.
Product
MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2025·2025-03-12
CircuitGuard Bacterial/Viral Filter Recalled for Plastic Connector Obstruction
Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.
Product
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1256-2025·2025-03-12
Medtronic Paradigm insulin pump recall for abnormal delivery during flight
Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.
Product
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1264-2025·2025-03-12
MiniMed Insulin Pump Models Recalled for Abnormal Delivery During Flight
Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.
Product
MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-1275-2025·2025-03-12
ET Rigid and Multi Dental Abutments Recalled for Incorrect Identification Stickers
Hiossen recalled ET Rigid and Multi dental abutments for incorrect identification stickers in packaging that misidentify product versions, risking improper placement during installation.
Product
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: ETRGA4524MP
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-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
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-1274-2025·2025-03-12
Hiossen Dental Abutments Misidentified on Patient Chart Stickers
Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.
Product
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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

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3651–3675 of 13449