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

13676–13700 of 27471

SevereFDA (Devices)·Z-2029-2020·2020-05-27
K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Size 28x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2030-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2008-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling 211 units of the Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2031-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage
K2M, Inc. is recalling Aleutian Interbody Spacer Systems because the welded spreader tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2025-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader Systems because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2034-2020·2020-05-27
Applied Medical Stealth Spring Clip Recall for Insufficient Vessel Occlusion
Applied Medical Resources Corp is recalling 2,240 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.
Product
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2053-2020·2020-05-27
Philips HeartStart XL Defibrillator Recalled for Rotary Switch Failure
Philips is recalling HeartStart XL Defibrillators because a faulty switch may prevent the device from turning on or delivering the correct shock energy.
Product
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2013-2020·2020-05-27
K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90121, UDI # 10888857108349, Size 24x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2012-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90115, UDI # 10888857108288, Size 24x12mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2021-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2023-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader Systems because the welded tips may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Size 28x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2027-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2035-2020·2020-05-27
Applied Medical Stealth Spring Clip Recall for Insufficient Vessel Occlusion
Applied Medical Resources Corp is recalling 2,240 units of Stealth Spring Clips due to a risk of insufficient vessel occlusion during surgery.
Product
STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2024-2020·2020-05-27
K2M Recalls Aleutian Lordotic Spreader Due to Breakage Risk
K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 10888857108707, Size 28x12mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2018-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 10888857108509, Size 24x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2047-2020·2020-05-27
Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent
Becton Dickinson & Co. is recalling BD BBL Gram Crystal Violet stain because increased artifacts may cause false-positive Gram stain results.
Product
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2074-2020·2020-05-27
Dako Autostainer Instruments Recalled for Potential False Negative Staining Results
Dako is recalling 796 Autostainer instruments because a missing syringe tray may cause excess buffer application, potentially leading to false negative staining results.
Product
Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2049-2020·2020-05-27
Cardinal Health Recalls B-Hydroxybutyrate LiquiColor Due to Temperature Abuse
Cardinal Health is recalling B-Hydroxybutyrate LiquiColor test kits because they were stored outside approved temperature ranges, which may lead to patient misdiagnosis.
Product
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2046-2020·2020-05-27
Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent
Becton Dickinson is recalling BD BBL Gram Crystal Violet stain reagent because it may produce artifacts that look like gram-positive cocci, potentially causing false-positive test results.
Product
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2011-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2072-2020·2020-05-27
Clinical Innovations Recalls Kiwi Vacuum Delivery System Due to Vacuum Failure
Clinical Innovations, LLC is recalling 2,340 units of the Kiwi Complete Vacuum Delivery System because the device may fail to generate or maintain vacuum during use.
Product
Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2087-2020·2020-05-27
Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect
Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.
Product
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-2042-2020·2020-05-27
Medline Silicone Foley Catheters Recalled Due to Loose Silicone Particulate
Medline Industries is recalling 330 units of 100% Silicone Foley Catheters because loose silicone particulate was found on the device shaft.
Product
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2014-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Interbody Spacer Systems Lordotic Spreader because the welded tip may break off during surgical procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2037-2020·2020-05-27
Applied Medical Recalls Stealth Spring Clips for Vascular Occlusion Failure
Applied Medical Resources Corp is recalling 750 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.
Product
STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Category
Medical Device
Distribution
Distributed nationwide

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13676–13700 of 27471