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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39501–39525 of 40356

  • ModerateFDA (Devices)·Z-0164-2013·2012-11-07

    ConMed Linvatec Recalls Mis-assembled CrossFT Punches for Suture Anchor Insertion

    ConMed Linvatec is recalling 2 units of CrossFT Punches (Lot 330889) because they were mis-assembled with the incorrect handle.

    Product
    "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2013·2012-11-07

    Siemens ADVIA Centaur BR Assay Recalled for Quality Control Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BR Assay kits because quality control results fell outside expected ranges.

    Product
    Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2013·2012-11-07

    Focus Diagnostics Recalls West Nile Virus IgG Test Kits

    Focus Diagnostics is recalling specific lots of West Nile Virus IgG test kits due to a higher false positive rate.

    Product
    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0188-2013·2012-11-07

    Roche Recalls cobas 4800 BRAF V600 Mutation Test Kits

    Roche Molecular Systems is recalling 44 kits of the cobas 4800 BRAF V600 Mutation Test because internal-use controls were incorrectly packaged into the product.

    Product
    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human…
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • SevereFDA (Devices)·Z-0152-2013·2012-10-31

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

    DePuy Mitek is recalling 25,393 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision.

    Product
    SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 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-0146-2013·2012-10-31

    DePuy Mitek Recalls 94 SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 94 SpiraLok 6.5mm anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 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-0154-2013·2012-10-31

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

    DePuy Mitek is recalling 4,151 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.

    Product
    SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 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
  • HighFDA (Devices)·Z-0114-2013·2012-10-31

    GE Healthcare Recalls innova 3100-IQ Mobile X-ray Systems Due to Filter Failure

    GE Healthcare is recalling 199 innova 3100-IQ mobile X-ray systems in the US due to a potential failure of the spectral filter mechanism inside the collimator.

    Product
    GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2013·2012-10-31

    Biosense Webster MobiCath Bi-Directional Guiding Sheath Recalled for Catheter Interaction

    Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths due to a potential interaction with therapeutic catheters that may cause them to self-advance.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide