The Recall Desk

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.

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

17251–17275 of 40124

  • 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-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
  • 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