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

15351–15375 of 27500

HighFDA (Devices)·Z-2350-2019·2019-08-28
Siemens ACUSON NX2 Ultrasound Systems Recalled for Acoustic Output Power Defect
Siemens is recalling ACUSON NX2 ultrasound systems because internal testing found transducers may exceed defined acoustic output power values.
Product
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2301-2019·2019-08-28
BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Product
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2299-2019·2019-08-28
BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Product
BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2306-2019·2019-08-28
BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling BD Vacutainer PST Blood Collection Tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Product
BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2019·2019-08-28
Siemens MAGNETOM Prisma MRI Devices Recalled for Quench Venting Port Issue
Siemens is recalling 17 MAGNETOM Prisma MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.
Product
MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-2297-2019·2019-08-28
BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Product
BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2352-2019·2019-08-28
Siemens ACUSON NX3 Ultrasound Systems Recalled for Acoustic Output Power Defect
Siemens is recalling 1,384 ACUSON NX3 diagnostic ultrasound systems worldwide because internal testing found transducers may exceed defined acoustic output power values.
Product
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2019·2019-08-28
Thoratec HeartMate 3 LVAS Implant Kit Recalled for Outflow Graft Leaks
Thoratec Corp. is recalling HeartMate 3 LVAS Implant Kits because an insufficiently seated C-Ring can cause the outflow graft to leak during implantation, rendering the device nonfunctional.
Product
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2019·2019-08-28
Siemens MAGNETOM Spectra MRI Devices Recalled for Quench Venting Port Issue
Siemens Medical Solutions is recalling two MAGNETOM Spectra MRI devices due to a potential open port in the quench venting system.
Product
MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-2320-2019·2019-08-28
Radiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities
Radiometer America Inc is recalling ABL90 FLEX Analyzers due to software security vulnerabilities that may cause device shutdowns or reboots, potentially delaying medical treatment.
Product
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-2307-2019·2019-08-28
BD Vacutainer Blood Collection Tubes Recalled for False COHb Results
Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
Product
BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2300-2019·2019-08-28
BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
Product
BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2264-2019·2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery to remove the broken end.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2066-2019·2019-08-21
Medline Primary Warmer Pack Recalled for Unsafe Aluminum Levels
Medline Industries is recalling 4,680 Primary Warmer Packs because the included Vyaire enFlow cartridge may release unsafe aluminum levels into the infusate.
Product
Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2261-2019·2019-08-21
Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2260-2019·2019-08-21
Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 640 units of Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2067-2019·2019-08-21
Medline Centurion Convenience Kits Recalled for Infusion Set Defect
Medline is recalling Centurion Convenience Kits containing BD Alaris Pump Infusion Sets due to a tubing defect that may cause over-infusion of medication.
Product
Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 11522558 (Centurion code 110931) contained inside kits DYNJ52509A and DYNJ52510A. Product Usage: The Centurion Primary Set Pack and Primary Warmer Pack Convenience Kit helps continuously or…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2263-2019·2019-08-21
Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2065-2019·2019-08-21
Fenwal Recalls Vigilant Agilia and Volumat MC Agilia Infusion Pump Software
Fenwal Inc is recalling 83 units of Vigilant Agilia and Volumat MC Agilia software to correct four anomalies and an alarm priority issue.
Product
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2262-2019·2019-08-21
Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 6,080 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2265-2019·2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2266-2019·2019-08-21
Medline Silicone Drain Recalled for Risk of Breaking During Use
Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.
Product
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2267-2019·2019-08-21
Smith & Nephew Wound Drain Recall Due to Breakage Risk
Smith & Nephew is recalling 15FR and 19FR channel wound drains because they may break during use or removal, requiring additional surgery.
Product
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2245-2019·2019-08-21
BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling 240 units of K-Wire Single Trocar 2.5x150mm due to a manufacturing flaw in the sterile barrier system.
Product
K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2281-2019·2019-08-21
Canadian Hospital Specialties Recalls Polyurethane Feeding Tubes Due to Connector Detachment
Canadian Hospital Specialties is recalling specific lots of MED-RX polyurethane feeding tubes because the connector may detach from the tube.
Product
MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
Category
Medical Device
Distribution
2 states

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15351–15375 of 27500