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

17326–17350 of 40248

ModerateFDA (Devices)·Z-2141-2020·2020-06-03
Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors
Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.
Product
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2108-2020·2020-06-03
Siemens ARTIS Pheno X-Ray Systems Recalled for Drivetrain Faults
Siemens is recalling 105 ARTIS Pheno X-ray systems because a drivetrain fault may prevent the C-arm from moving, requiring field service to restore operation.
Product
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2106-2020·2020-06-03
Medtronic Guardian Connect App iOS Recall for Battery Life Issues
Medtronic is recalling the Guardian Connect App for iOS due to shortened transmitter battery life on specific iPhone, iPad, and iPod Touch devices.
Product
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2142-2020·2020-06-03
Inpeco Aptio Automation System Recalled for Sample Association Error
Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.
Product
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2129-2020·2020-06-03
Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns
Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing their sterility.
Product
Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2130-2020·2020-06-03
Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns
Teleflex Medical is recalling 800 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing sterility.
Product
Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2124-2020·2020-06-03
Boston Scientific Recalls Spinal Cord Stimulation Lead Extensions Due to Labeling Error
Boston Scientific is voluntarily removing 41 units of spinal cord stimulation lead extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Product
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2112-2020·2020-06-03
CooperSurgical Dilator/Sound Set Recalled for Potential Sterile Pouch Seal Compromise
CooperSurgical is recalling 1,740 units of Dilator/Sound Sets because the sterile pouch seal may be compromised, potentially affecting sterility.
Product
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2111-2020·2020-06-03
GE Healthcare Recalls Giraffe Shuttle Upgrade Kits Due to Battery Odor
GE Healthcare is recalling Giraffe Shuttle upgrade kits because the batteries emit a strong sulfur odor during charging.
Product
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2140-2020·2020-06-03
Inpeco FlexLab Automation System Recalled for Sample Association Errors
Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.
Product
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2122-2020·2020-06-03
Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error
Boston Scientific is voluntarily removing certain spinal cord stimulation leads and extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Product
The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2121-2020·2020-06-03
Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error
Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Product
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2119-2020·2020-06-03
Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error
Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Product
ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1)…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2120-2020·2020-06-03
Boston Scientific Recalls Spinal Cord Stimulation Extension Kits Due to Labeling Error
Boston Scientific is voluntarily removing 19 units of 35 cm 8 Contact Extension Kits because the 'use by date' on the label is later than the correct date.
Product
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2123-2020·2020-06-03
Boston Scientific Recalls Spinal Cord Stimulation Adapters Due to Labeling Error
Boston Scientific is voluntarily removing two Precision M8 Adapters because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.
Product
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2125-2020·2020-06-03
Boston Scientific Recalls Deep Brain Stimulation Lead Extensions Due to Labeling Error
Boston Scientific is voluntarily removing specific Deep Brain Stimulation lead extensions because the 'use by date' on the label is later than the correct date.
Product
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2022-2020·2020-05-27
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 # 5203-90153, UDI # 10888857108660, Size 28x8mm, 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-2017-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled 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 # 5203-90135, UDI # 10888857108486, Size 24x4mm, 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-2060-2020·2020-05-27
Bovie Medical Recalls Renuvion J-Plasma Precise Open Handpieces Due to Fracture Risk
Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Open Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.
Product
Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2015-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled 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 # 5203-90125, UDI # 10888857108387, Size 24x8mm, 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-2009-2020·2020-05-27
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 spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 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-2010-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled for 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 # 5203-90111, UDI # 10888857108240, Size 24x8mm, 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-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

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17326–17350 of 40248