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

12401–12425 of 27470

SevereFDA (Devices)·Z-0593-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk
Cook Inc. is recalling 458 Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0597-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0595-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0610-2021·2020-12-30
Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk
Cook Inc. is recalling 902 Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0602-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0611-2021·2020-12-30
Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Product
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0707-2021·2020-12-30
ICU Medical Recalls ChemoLock Administration Sets Due to Molding Defect
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Product
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0598-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0600-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0604-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0596-2021·2020-12-30
Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications
The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0594-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0591-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0607-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0702-2021·2020-12-30
ICU Medical Recalls Spiros Male Luer Connectors Due to Molding Defect
ICU Medical is recalling Spiros male luer connectors and administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2021·2020-12-30
Siemens ADVIA GGT Reagent Recalled for Low-End Repeatability Imprecision
Siemens Healthcare Diagnostics is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent because it may show repeatability imprecision outside of listed performance data.
Product
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0708-2021·2020-12-30
ICU Medical Recalls Oncology and Administration Sets Due to Molding Defect
ICU Medical is recalling specific oncology and administration sets because a molding defect in male luers may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2021·2020-12-30
GA Health Company Recalls STOPCON Disposable Valves Due to Defects
GA Health Company is recalling 12,800 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
Product
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0660-2021·2020-12-30
Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks
Boston Scientific is recalling 8,453 IcePearl 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Product
IcePearl" 2.1 CX 90¿ Cryoablation Needle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0697-2021·2020-12-30
Haag-Streit Surgical Floor Stands Recalled for Software Error
Haag-Streit USA Inc. is recalling surgical floor stands and operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released.
Product
Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0650-2021·2020-12-30
ConMed Infinity ACL Tibial Elbow Guide Recalled for Misalignment
ConMed Corporation is recalling 73 units of the Infinity ACL Tibial Elbow Guide because the tips may be misaligned, potentially affecting the accuracy of the guide system.
Product
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0667-2021·2020-12-30
Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks
Boston Scientific is recalling 255 IceRod 1.5 PLUS Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Product
IceRod" 1.5 PLUS Cryoablation Needle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0666-2021·2020-12-30
Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks
Boston Scientific is recalling 4,645 IceRod 1.5 PLUS 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.
Product
IceRod" 1.5 PLUS 90¿ Cryoablation Needle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0655-2021·2020-12-30
Hardy Diagnostics Recalls Viral Transport Media Due to Contamination Risk
Hardy Diagnostics is recalling Viral Transport Media due to potential contamination that may compromise COVID-19 test detection.
Product
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0711-2021·2020-12-30
ICU Medical Recalls Spiros Blood Sets Due to Molding Defect
ICU Medical is recalling Spiros blood sets because a molding defect may cause leaks, risking fluid contamination or air-in-line.
Product
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Category
Medical Device
Distribution
Distributed nationwide

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12401–12425 of 27470