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

18926–18950 of 40124

HighFDA (Devices)·Z-0465-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Compromise
Cook Inc. is recalling 33 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect
Cook Inc. is recalling 95 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 93 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0479-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 30 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0460-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0468-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 232 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0478-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 195 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0501-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Filled Non-Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0416-2020·2019-11-27
Guardia Access Embryo Transfer Catheter Recall Due to Bent Tips
The FDA is recalling the Guardia Access Embryo Transfer Catheter because bent tips can make insertion difficult, potentially requiring repeat procedures. No injuries have been reported, so the recall is classified as moderate severity.
Product
Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0505-2020·2019-11-27
Angiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect
Angiodynamics Inc. is recalling 582 XCELA implantable port kits because snap lock connectors may not meet specifications, preventing catheter insertion.
Product
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0407-2020·2019-11-27
Centurion Medical Products Recalls Epistaxis Tray Kits Containing Nasal Spray
Centurion Medical Products is recalling 525 Epistaxis Tray Kits because they contain major nasal decongestant spray.
Product
EPISTAXIS TRAY Kit Code: MNS10165
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0503-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Plastic Non-Filled Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Plastic Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0504-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
Angiodynamics Inc. is recalling BIOFLO 8F catheters because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0417-2020·2019-11-27
Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System Recall for Warning Updates
Cincinnati Sub-Zero is recalling 3,932 Blanketrol III Hyper-Hypothermia Systems to add warnings about tissue damage from extended high temperatures and clarify automatic mode usage.
Product
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0414-2020·2019-11-27
Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal
Randox Laboratories is recalling Liquid Cardiac Controls (CQ5053) to remove N-proBNP claims due to decreased recovery in recent lots.
Product
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0477-2020·2019-11-27
Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 135 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are distributed worldwide.
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0413-2020·2019-11-27
Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal
Randox Laboratories is removing N-proBNP claims from Liquid Cardiac Controls due to decreased recovery in recent lots.
Product
Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0506-2020·2019-11-27
Cook Inc. Recalls Pneumothorax Trays Due to Sterility Compromise Risk
Cook Inc. is recalling 41 units of Pneumothorax Trays because a perforation line may be positioned over the sterile area, potentially compromising device sterility.
Product
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0411-2020·2019-11-27
Angiodynamics Recalls Mislabelled Starburst Electrosurgical Devices
Angiodynamics Inc. is recalling 30 Starburst Talon Semi-Flex Electrosurgical Devices that were incorrectly labelled as Starburst MRI Semi-Flex devices, potentially causing procedural delays.
Product
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0412-2020·2019-11-27
Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal
Randox Laboratories is recalling Liquid Cardiac Controls (CQ5051) to remove N-proBNP claims due to decreased recovery in recent lots.
Product
Randox Liquid Cardiac Controls Catalogue Number CQ5051
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0507-2020·2019-11-27
Nucryo PolarCath Balloon Catheters Recalled for Incorrect Sterilization Labeling
Nucryo Vascular Inc. is recalling 49 PolarCath Balloon Catheters because they were mislabeled as ethylene oxide sterilized instead of E-beam sterilized.
Product
The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths.…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0511-2020·2019-11-27
Neocis Guidance System Fiducial Array Recalled for Measurement Mismatch
Neocis Inc. is recalling three units of the Neocis Guidance System Fiducial Array because they may mismatch measurement files, resulting in a failed landmark check.
Product
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0502-2020·2019-11-27
Angiodynamics Recalls BIOFLO 8F Single Titanium Non-Filled Valved Ports
Angiodynamics Inc. is recalling BIOFLO 8F Single Titanium Non-Filled Valved ports because snap lock connectors may not meet specifications, preventing catheter insertion and delaying implantation.
Product
BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0493-2020·2019-11-27
Hager & Meisinger Recalls Dental Carbide Burs Due to Packaging Error
Hager & Meisinger is recalling 2,500 dental carbide burs because a 1.0 mm blade may have been packaged in 0.9 mm packaging.
Product
Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0353-2020·2019-11-20
Heritage Medical 2000 Vascular Beds Recalled for Sudden Head Drop Hazard
Heritage Medical Products is recalling 167 2000 Vascular beds due to a potential for the head of the bed to drop suddenly while a patient is lying on it.
Product
2000 Vascular with 30 Degree option
Category
Medical Device
Distribution
Distributed nationwide

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18926–18950 of 40124