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

17401–17425 of 40124

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
ModerateFDA (Devices)·Z-1998-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1964-2020·2020-05-20
Bard PowerPort ClearVUE Slim Implantable Port Recalled for Incorrect Catheter Lock Size
Bard Peripheral Vascular Inc is recalling 200 units of PowerPort ClearVUE Slim Implantable Ports because the catheter locks may be 8Fr instead of the labeled 6Fr.
Product
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1999-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1928-2020·2020-05-20
Edwards HemoSphere Oximetry Cable Recalled for Inconsistent Connector Crimping
Edwards Lifesciences is recalling 35 HemoSphere oximetry cables due to intermittent communication caused by inconsistent crimping of connectors.
Product
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1942-2020·2020-05-20
Karl Storz Endoscopy Recalls Insufflation Tubing Due to Ethylene Oxide Residues
Karl Storz Endoscopy is recalling sterile insufflation tubing because it may contain higher ethylene oxide residues than the acceptable level.
Product
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-1970-2020·2020-05-20
C.R. Bard Recalls SureStep Foley Tray Systems Due to Residue
C.R. Bard is recalling 8,392 SureStep Foley Tray Systems because a white paper-type residue may be attached to the catheter.
Product
SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2002-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 15 units of Central Venous Catheters because the included guidewire cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2000-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2001-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1971-2020·2020-05-20
BD Biosciences Recalls CD45 Reagent Due to False Positive Reactions
Becton, Dickinson and Company is recalling 1,473 vials of Analyte specific reagent (CD45) because of false positive reactions. The product is used for in vitro diagnostic testing.
Product
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1962-2020·2020-05-20
Gore DrySeal Flex Introducer Sheath Recalled for Incorrect Size Labeling
W. L. Gore & Associates is recalling 141 Gore DrySeal Flex Introducer Sheaths because 16Fr devices were mislabeled as 14Fr.
Product
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1997-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect
ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-1996-2020·2020-05-20
ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.
Product
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-2006-2020·2020-05-20
Ra Medical Systems Recalls DABRA Catheters Due to Calibration Failure Risk
Ra Medical Systems is recalling DABRA catheters because the actual shelf life is shorter than labeled, potentially causing calibration failures.
Product
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm)…
Category
Medical Device
Distribution
Distributed nationwide

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17401–17425 of 40124