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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27101–27125 of 27681

  • SevereFDA (Devices)·Z-0173-2013·2012-11-07

    Ventlab V*Care Infant Resuscitator Recalled for Potential Volume Leakage

    Ventlab Corporation is recalling V*Care Infant Resuscitators due to a possible volume leakage through the inlet valve during compressions.

    Product
    V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2013·2012-11-07

    Oscor Recalls Myocardial Heart Wires Due to Spacing Defect

    Oscor, Inc. is recalling specific models of myocardial heart wires because the spacing between the anchoring zig-zag and the electrode is out of specification.

    Product
    Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0160-2013·2012-11-07

    Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Connector Detachment Risk

    Maquet Cardiovascular is recalling QUADROX oxygenators because the blood outlet connector may detach from the device during use.

    Product
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2013·2012-11-07

    Sorin SCP Pump Control Panel Recalled for Circuit Board Malfunction

    Sorin Group USA is recalling SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2013·2012-11-07

    Progressive Medical Recalls Endoscopic Dissector Due to Tip Unraveling Risk

    Progressive Medical Inc is recalling 124 boxes of PMI Endoscopic Dissectors because the tip could come loose or unravel during use.

    Product
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2013·2012-11-07

    Varian ARIA Radiation Oncology Software Recall Due to Treatment Plan Error

    Varian Medical Systems is recalling ARIA Radiation Oncology Version 11 software because monitor units may be incorrect when continuing partial treatment.

    Product
    ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2013·2012-11-07

    Vital Images Recalls Vitrea Software Due to Calcium Score Errors

    Vital Images is recalling Vitrea software versions due to potential errors in calcium score values within restored study snapshots.

    Product
    Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2013·2012-11-07

    Sorin SCP Pump Control Panel Recalled for Display Malfunction

    Sorin Group USA is recalling 12 SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2013·2012-11-07

    Stryker Spine Recalls Aviator Drill Bits Due to Over-Drilling Risk

    Stryker Spine is recalling Aviator Drill Bits because they are 10 mm longer than Reflex Hybrid bits and not interchangeable, posing a risk of over-drilling.

    Product
    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0153-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 39,362 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0142-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 314 units of SpiraLok 6.5mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.

    Product
    SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0147-2013·2012-10-31

    DePuy Mitek Recalls SPIRALOK Bone Fixation Anchors Due to Fracture

    DePuy Mitek is recalling 66 SPIRALOK bone fixation anchors because they can fracture after surgery, requiring patients to undergo revision surgery.

    Product
    Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0143-2013·2012-10-31

    SpiraLok 6.5mm Anchors Recalled Due to Post-Operative Fracture

    DePuy Mitek is recalling 372 units of SpiraLok 6.5mm anchors because they fractured after surgery, requiring patient revision.

    Product
    SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0149-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers all lot codes distributed worldwide.

    Product
    SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0111-2013·2012-10-31

    Ethicon Recalls EVICEL Fibrin Sealant Pressure Regulators Due to Embolism Reports

    Ethicon is recalling EVICEL Fibrin Sealant pressure regulators after reports of air or gas embolism associated with the use of spray devices.

    Product
    EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0145-2013·2012-10-31

    SpiraLok 5.0mm Anchors Recalled for Post-Operative Fracture Risk

    DePuy Mitek is recalling 232 units of SpiraLok 5.0mm anchors due to post-operative fractures requiring patient revision surgery.

    Product
    SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0140-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 1,315 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0155-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 4,321 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0151-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling SpiraLok 6.5 anchors because they may fracture after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0150-2013·2012-10-31

    DePuy Mitek Recalls Seven SpiraLok 6.5 Anchors Due to Fracture Risk

    DePuy Mitek is recalling seven SpiraLok 6.5 anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0070-2013·2012-10-31

    Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunctions

    Hospira is recalling Symbiq Two Channel Infusers because the touchscreen may fail to respond or register incorrect values, potentially causing medication delivery errors.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0069-2013·2012-10-31

    Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunction

    Hospira is recalling 19,614 Symbiq One Channel Infusion Pumps because the touchscreen may fail to respond or register incorrect values, potentially leading to medication dosing errors.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0141-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 2,560 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.

    Product
    SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0144-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk

    DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.

    Product
    SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0148-2013·2012-10-31

    DePuy Mitek Recalls Seven SpiraLok 5.0 Anchors Due to Fracture

    DePuy Mitek is recalling seven SpiraLok 5.0 anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide