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

23751–23775 of 40175

SevereFDA (Devices)·Z-1483-2018·2018-05-16
Draeger Fabius Tiro Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling 26 Fabius Tiro anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.
Product
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1716-2018·2018-05-16
Datascope Recalls Custom Tubing Packs Due to Potential Seal Separation
Datascope is recalling 22 units of BEQ-TOP 33700 ECC 3/8" PACK custom tubing kits because a seal defect may cause balloon collapse and reduced blood flow.
Product
BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1568-2018·2018-05-16
Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1707-2018·2018-05-16
Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling the Better Bladder device in some custom tubing kits because seal separation may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.
Product
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1713-2018·2018-05-16
Datascope Recalls Better Bladder Device in Custom Tubing Kits
Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may cause balloon collapse and reduced blood flow.
Product
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1718-2018·2018-05-16
Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope is recalling 10 custom tubing kits because a seal defect may allow air to enter the housing, causing the balloon to collapse and reducing blood flow in ECMO circuits.
Product
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1566-2018·2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitators Due to Mask Sticking
Vyaire Medical is recalling 3,600 AirLife Infant Resuscitators because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1484-2018·2018-05-16
Draeger Fabius Tiro M Anesthesia Machine Recalled for Ventilator Failure Risk
Draeger Medical is recalling one Fabius Tiro M anesthesia machine because automatic ventilation may fail if motor position detection is disturbed.
Product
Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1730-2018·2018-05-16
Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope is recalling 18 custom tubing kits because a seal defect may cause the Better Bladder balloon to collapse, potentially reducing blood flow in ECMO circuits.
Product
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1559-2018·2018-05-16
Vyaire Medical Recalls AirLife Infant Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 8,124 AirLife Infant Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1572-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 720 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1733-2018·2018-05-16
Datascope recalls custom pediatric ECMO tubing kits due to seal defect
Datascope is recalling two custom pediatric ECMO tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow.
Product
BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1711-2018·2018-05-16
Datascope Better Bladder Device Recalled Due to Seal Separation Risk
Datascope is recalling Better Bladder devices in custom tubing kits because seal separation may cause balloon collapse and reduced ECMO blood flow.
Product
BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1723-2018·2018-05-16
Datascope Recalls Better Bladder Custom Tubing Kits Due to Seal Separation
Datascope Corporation is recalling 10 units of the BEQ-T 25501 Better Bladder Pack, Custom Tubing Kit. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.
Product
BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1575-2018·2018-05-16
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 270 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1623-2018·2018-05-16
Boston Scientific Recalls Posterior LITE Sutures Due to Breakage Risk
Boston Scientific Corporation is recalling 1,541 units of the Posterior LITE w/ Capio SLIM device because the sutures may break or detach.
Product
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1558-2018·2018-05-16
Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 42 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1699-2018·2018-05-16
Siemens Recalls Syngo.plaza Software to Prevent Patient Misdiagnosis
Siemens Medical Solutions is recalling Syngo.plaza software due to format errors in study dates and issues with legacy presentation states that could lead to patient misdiagnosis.
Product
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1728-2018·2018-05-16
Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope Corporation is recalling BEQ-TOP 22301 Custom Tubing Kits because seal separation may allow air to enter the housing, causing the balloon to collapse and reducing blood flow.
Product
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1555-2018·2018-05-16
Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking
Vyaire Medical is recalling 24 AirLife Pediatric Resuscitation devices because the mask may stick to the elbow, making it difficult to disconnect.
Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1706-2018·2018-05-16
Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling specific custom tubing kits because the Better Bladder device may allow air to enter, potentially reducing blood flow in ECMO circuits.
Product
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1731-2018·2018-05-16
Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling 11 custom tubing kits containing the Better Bladder device due to a seal defect that may cause balloon collapse and reduced blood flow.
Product
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1739-2018·2018-05-16
Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues
Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
Product
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1712-2018·2018-05-16
Datascope Better Bladder Device Recalled Due to Seal Separation Risk
Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.
Product
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1721-2018·2018-05-16
Datascope Custom Tubing Kit Recall Due to Seal Separation
Datascope is recalling 9 custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.
Product
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
Category
Medical Device
Distribution
13 states

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