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

17376–17400 of 40124

HighFDA (Devices)·Z-1936-2020·2020-05-20
Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect
Argon Medical Devices is recalling 150 Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.
Product
Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1958-2020·2020-05-20
Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk
Siemens is recalling 16 Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage and shock.
Product
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1994-2020·2020-05-20
Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA is recalling specific Dover Foley catheters because their temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.
Product
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1953-2020·2020-05-20
Cardiac Assist Recalls Six TandemHeart Pump Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling six TandemHeart pump kits because an assembly error may prevent the device from priming.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1980-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 4,187 saline flush syringes used in vascular kits because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1992-2020·2020-05-20
FDA Recalls Dover Foley Catheters Due to Temperature Sensor Failures
FDA is recalling Dover Foley catheters because their temperature sensors failed to meet calibration standards, which could lead to incorrect patient diagnoses.
Product
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1973-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 6,254 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1972-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects
Access Scientific LLC is recalling 2,697 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1947-2020·2020-05-20
Sunrise Medical Recalls Quickie and Zippie Powered Wheelchairs Due to Controller Error
Sunrise Medical is recalling specific Quickie and Zippie powered wheelchairs because a controller programming error allows users to set motor parameters beyond safe limits.
Product
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2003-2020·2020-05-20
Inpeco FlexLab Interface Module Recalled for Sample Cross-Contamination Risk
Inpeco S.A. is recalling 82 FlexLab Interface Modules because a timeout error could cause sample cross-contamination.
Product
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1948-2020·2020-05-20
Cardiac Assist Recalls TandemHeart Pump Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 10 TandemHeart Pump Kits because an assembly error may prevent the device from priming.
Product
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1968-2020·2020-05-20
BD Alaris PCEA Administration Set Recalled for Potential Leakage
BD Switzerland is recalling 110,350 units of Alaris PCEA Administration Sets due to a potential leak at the luer connection that may cause inadequate pain control.
Product
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1986-2020·2020-05-20
Dover Silicone Foley Catheters Recalled for Temperature Measurement Failures
FDA is recalling Dover 100% Silicone Foley Catheters because they failed to meet temperature sensing tolerances, potentially leading to incorrect diagnoses.
Product
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1982-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Defects
Access Scientific LLC is recalling 50 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1961-2020·2020-05-20
Intuitive Surgical Recalls da Vinci X Systems Due to Arm Fault
Intuitive Surgical is recalling 74 da Vinci X Surgical Systems because a manufacturing variation in the arm can cause a fault error and loss of functionality during surgery.
Product
da Vinci X Surgical System
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1981-2020·2020-05-20
Access Scientific Recalls Pediatric Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 120 units of BD PosiFlush SF Saline Flush Syringes used in pediatric kits because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1993-2020·2020-05-20
Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA is recalling 120 units of Dover Foley catheters because temperature sensors failed to meet calibration standards, potentially leading to incorrect diagnoses.
Product
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1988-2020·2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
Covidien is recalling Dover 100% Silicone Foley trays because the temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.
Product
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1985-2020·2020-05-20
Dover Foley Catheters Recalled for Temperature Sensor Inaccuracy
FDA is recalling 480 Dover Foley catheters with temperature sensors that failed to meet accuracy standards, posing a risk of incorrect patient diagnosis.
Product
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1935-2020·2020-05-20
Stryker Power-PRO TL Ambulance Cots Recalled for Crash Test Non-Compliance
Stryker is recalling 34 Power-PRO TL ambulance cots in the UK because they may not meet the crash test standard BS EN 1789.
Product
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1966-2020·2020-05-20
Magstim Recalls Rapid2 Stim Interconnecting Cables Due to Potential Failure
The Magstim Company Limited is recalling 71 Rapid2 PSU Stim Interconnecting Cables because the high-voltage cable may fail. The recall covers units distributed worldwide.
Product
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1978-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Syringes Due to Packaging Holes
Access Scientific LLC is recalling 30 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1975-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Syringes Due to Packaging Holes
Access Scientific LLC is recalling 6,066 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2020·2020-05-20
Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents
Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.
Product
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system.…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1984-2020·2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA recalls 468 Dover Foley catheters with temperature sensors that failed accuracy tests. Incorrect readings could lead to misdiagnosis.
Product
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Category
Medical Device
Distribution
Distributed nationwide

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17376–17400 of 40124