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 the agency’s own highest classification or reported deaths or serious injuries, 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

20851–20875 of 40248

HighFDA (Devices)·Z-1325-2019·2019-05-22
Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Errors
Pentax of America Inc is recalling 157 C2 CryoBalloon Standard Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.
Product
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of…
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1333-2019·2019-05-22
Shippert Medical Technologies Recalls Tissu-Trans FILTRON 1000 Medical Devices
Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 1000 sterile, disposable, one-patient use devices due to a Class II safety concern.
Product
Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1349-2019·2019-05-22
Stanley Security M200 Fall Monitoring System Recalled for Damaged Capacitor
Stanley Security Solutions is recalling 1,101 M200 Fall Monitoring Systems due to a damaged capacitor on the printed circuit board.
Product
M200 Fall Monitoring System
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1332-2019·2019-05-22
Shippert Medical Technologies Recalls Tissu-Trans FILTRON 500 Due to Pouch Integrity Concerns
Shippert Medical Technologies is recalling Tissu-Trans FILTRON 500 sterile pouches because a cut or hole in the packaging may compromise the product's sterility.
Product
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1320-2019·2019-05-22
Philips SureSigns VS3 Monitor Software Defect Recall
Philips is recalling 3,177 SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1324-2019·2019-05-22
Philips SureSigns VS4 Monitor Software Defect Recall
Philips is recalling 366 SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2019·2019-05-22
Shippert Medical Technologies Recalls Tissu-Trans FILTRON 2000 Medical Devices
Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 2000 sterile, disposable, one-patient use devices due to a Class II classification.
Product
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1335-2019·2019-05-22
Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Pouch Integrity Concerns
Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 sterile pouches because a cut or hole may compromise sterility.
Product
Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1318-2019·2019-05-22
Philips SureSigns VS3 Monitor Software Defect Recalled
Philips is recalling 518 SureSigns VS3 monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1353-2019·2019-05-22
Abbott ARCHITECT Estradiol Reagent Kit Recall for Mifepristone Interference
Abbott is recalling ARCHITECT Estradiol Reagent Kits because patient results may be falsely elevated for individuals currently or recently treated with Mifepristone.
Product
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2019·2019-05-22
Stryker Power-LOAD Cot Fastening System Recalled for Broken Floor Plates
Stryker is recalling 3,285 Power-LOAD Cot Fastening Systems because the floor plates holding ambulance cot anchors may be broken.
Product
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1315-2019·2019-05-22
R82 Wombat Living Activity Chair Recalled for Plastic Joint Breakage
R82 A/S is recalling 68 Wombat Living activity chairs (wheelchairs) in North Carolina due to reports of the plastic joint connecting the back to the seat breaking.
Product
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1323-2019·2019-05-22
Philips SureSigns VS4 Monitor Software Defect Recall
Philips is recalling SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Product
SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2019·2019-05-22
Shippert Medical Technologies Recalls Tissu-Trans FILTRON 250 Due to Pouch Integrity Concerns
Shippert Medical Technologies is recalling Tissu-Trans FILTRON 250 sterile filters because the pouch integrity cannot be assured without visual examination.
Product
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1327-2019·2019-05-22
Pentax Medical C2 CryoBalloon Catheter Recalled for Dose Transmission Error
PENTAX of America Inc is recalling 4 C2 CryoBalloon Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.
Product
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of…
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1317-2019·2019-05-22
Philips SureSigns VS3 NBP Recall for Pulse Rate Measurement Limitation
Philips is recalling SureSigns VS3 NBP monitors because software prevents the display and alarm for pulse rates above 240 beats per minute.
Product
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2019·2019-05-22
Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage
Siemens is recalling 459 Artis Q angiography systems because the floating tabletop may become blocked after a collision sensor activates.
Product
Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1329-2019·2019-05-22
Fungitell Kit Recalled for Missing or Incorrect Components
Associates of Cape Cod, Inc. is recalling Fungitell Kits due to potential missing or incorrect components.
Product
Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detection of (1-3)Beta-D Glucan in the serum of patients with symptoms of,or medical conditions predisposing the patient to, invasive fungal…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1345-2019·2019-05-22
MediPress Pneumatic Compression System Recalled for Missing Premarket Clearance
Compass Health Brands is recalling MediPress pneumatic compression systems because a product design change lacked proper FDA premarket clearance.
Product
MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1316-2019·2019-05-22
Abbott Alinity ci-series System Control Module Software Recall
Abbott is recalling Alinity ci-series System Control Module software version 2.5.1 due to potential performance issues.
Product
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1344-2019·2019-05-22
MediPress Pneumatic Compression System Recalled for Lack of Clearance
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Product
MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1346-2019·2019-05-22
MediPress Pneumatic Compression System Recalled for Lack of Clearance
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Product
MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1365-2019·2019-05-22
Arrow PICC Recall for Incorrect Length Labeling
Arrow International Inc. is recalling Arrow PICC kits because some may contain a different length than labeled.
Product
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1348-2019·2019-05-22
MediPress Pneumatic Compression System Recalled for Lack of Clearance
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Product
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1343-2019·2019-05-22
MediPress Pneumatic Compression System Recalled for Missing Premarket Clearance
Compass Health Brands is recalling the MediPress pneumatic compression system because a design change lacked proper FDA premarket clearance.
Product
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Category
Medical Device
Distribution
36 states

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