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

13751–13775 of 27500

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
HighFDA (Devices)·Z-1987-2020·2020-05-20
Dover Foley Catheter Recalled for Temperature Sensor Calibration Failures
Covidien is recalling Dover Foley catheters with temperature sensors that failed to meet calibration tolerances, posing a risk of incorrect diagnosis.
Product
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - 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-1990-2020·2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA is recalling Dover silicone Foley catheters because temperature sensors failed to meet calibration standards, risking incorrect patient diagnoses.
Product
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 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: P4P16TSD - Product Usage: for Drainage of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2020·2020-05-20
Cardiac Assist Recalls TandemLung Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling two TandemLung Kit units because an assembly error may prevent the pump from priming.
Product
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - 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-1952-2020·2020-05-20
Cardiac Assist Recalls TandemHeart ProtekDuo Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 46 TandemHeart ProtekDuo Kits due to an assembly error that may cause failure to prime.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - 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-1979-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1983-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 110 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 Max Barrier Kit. REF/UDI / 94116/10859821006237 - 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-1951-2020·2020-05-20
Cardiac Assist Recalls 38 TandemHeart ProtekDuo Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 38 TandemHeart ProtekDuo Kits because an assembly error may prevent the pump from priming.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - 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-1967-2020·2020-05-20
BD Alaris PCEA Administration Set Recalled for Potential Leaking
BD is recalling 110,350 Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.
Product
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - 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-1956-2020·2020-05-20
Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error
Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.
Product
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2007-2020·2020-05-20
Edwards Lifesciences Recalls Sterile Oxymetry Oligon Catheter Kits
Edwards Lifesciences is recalling 597 sterile catheter kits because their packaging was compromised, potentially affecting sterility.
Product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1963-2020·2020-05-20
DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes
DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.
Product
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e.…
Category
Medical Device
Distribution
8 states
CriticalFDA (Devices)·Z-1847-2020·2020-05-13
Applied Medical Recalls Bard Embolectomy Catheters Due to Tip Separation
Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.
Product
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1842-2020·2020-05-13
Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Defect
Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a programming error prevents the system from measuring tip temperature, which may stop auto-cooling and cause patient injury.
Product
Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1900-2020·2020-05-13
Howmedica Recalls Cortoss Bone Augmentation Material Due to Temperature Violations
Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.
Product
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Category
Medical Device
Distribution
15 states
SevereFDA (Devices)·Z-1791-2020·2020-05-13
Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation
Argon Medical Devices is recalling specific 0.035-inch guidewires because the stiffness of the soft end caused tissue perforation. The affected units were distributed to several countries outside the United States.
Product
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1843-2020·2020-05-13
Philips TEE Transducers Recalled Due to Temperature Measurement Failure
Philips Ultrasound Inc is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.
Product
Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1915-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error
ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.
Product
REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
Category
Medical Device
Distribution
44 states

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13751–13775 of 27500