State

Delaware product recalls

73,576 recalls have nationwide distribution and so reach Delaware. 3,438 additional recalls listed Delaware specifically in their distribution scope.

What the numbers show

Total: 3,438
Critical: 477
Severe: 1,110
Most recent: 2026-10-14

Of the 3,438 recalls naming Delaware we have scored against our rubric, 477 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,110 (32%) are Severe.

Which agencies issued them

These figures cover only the 3,438 recalls whose distribution notice names Delaware specifically. The 73,576 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

27801–27825 of 77014

SevereFDA (Devices)·Z-0592-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 383 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-4.0-35-55-RB-HFANL1-HC, Order Number G56234 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 (Drugs)·D-0174-2021·2020-12-30
Morton Grove Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities
Morton Grove Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution because it failed impurity specifications, including an unknown degradant.
Product
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0606-2021·2020-12-30
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-8.0-35-55-RB-HFANL0-HC, Order Number G56233 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-0603-2021·2020-12-30
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, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 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-0605-2021·2020-12-30
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-7.0-35-70-RB-HFANL1-HC, Order Number G56227 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-0609-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling 631 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-8.0-35-70-RB-HFANL1-HC, Order Number G56228 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-0608-2021·2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 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-0601-2021·2020-12-30
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-6.0-35-70-RB-HFANL1-HC, Order Number G56226 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-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