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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36676–36700 of 40449

  • HighFDA (Devices)·Z-0711-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 38 units of Extractor Pro XL Retrieval Balloon Catheters due to potential defects in skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2014·2014-01-22

    King Systems Recalls Supraglottic Airway Kits Due to Incorrect Component

    King Systems Corp. is recalling King LTSD Kit Size 4 supraglottic airway devices because some packages contained KLTD214 airways that lack a required gastric suction tube lumen.

    Product
    King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0724-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity

    Boston Scientific is recalling 3,300 TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0736-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain tubing may leak or disconnect

    Atrium Medical Corporation is recalling 624 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2014·2014-01-22

    Anspach MIA 16 Minimally Invasive Attachment Recalled for Sterility Failure

    The Anspach Effort, Inc. is recalling 183 Anspach MIA 16 attachments because they did not reach the expected sterility assurance level.

    Product
    Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity

    Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling carbide cutting burrs and drums because some fractured during use. The products are used for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2014·2014-01-22

    Teleflex Recalls Electrosurgical Suction Tubes Due to Sterility Concerns

    Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices were distributed nationwide.

    Product
    Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The devices are intended for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2014·2014-01-22

    Anspach Bone Cutting Burs Recalled for Potential Sterile Barrier Breach

    The Anspach Effort, Inc. is recalling single-use sterile bone cutting burs and irrigation clips due to observed layer separation that may compromise the sterile barrier.

    Product
    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recalled

    Atrium Medical Corporation is recalling 361 units of the Ocean Water Seal Chest Drain ATS Blood Recovery System because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2014·2014-01-22

    GE Healthcare Recalls Merge Mammo Workstation Software Due to Image Display Errors

    GE Healthcare is recalling 28 units of Merge Mammo software version 8.0.2 because images may display out of sync with the navigator, potentially leading to misdiagnosis.

    Product
    Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT.…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0768-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0734-2014·2014-01-22

    Remel Recalls Oxoid Antimicrobial Susceptibility Testing Discs Due to Impregnation Defect

    Remel Inc is recalling Oxoid Antimicrobial Susceptibility Testing Discs because individual discs may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

    Product
    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2014·2014-01-22

    Anspach MCA Cutting Burr Recalled for Inadequate Labeling Instructions

    The Anspach Effort, Inc. is recalling MCA Cutting Burs because the current directions for use do not provide sufficient details regarding the intended use for these specific burs.

    Product
    Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0731-2014·2014-01-22

    GE Centricity PACS System Recalled for Potential Image Loss During Transfer

    GE Healthcare is recalling Centricity PACS System versions 3.X and 4.X due to a potential loss of diagnostic images during transfers between servers.

    Product
    Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0717-2014·2014-01-22

    Leica Biosystems Recalls BOND Polymer Refine Red Detection Due to Fungal Contamination

    Leica Biosystems is recalling BOND Polymer Refine Red Detection kits because they may contain fungal contaminants that can cause staining sensitivity loss or fluid delivery obstructions.

    Product
    Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-0778-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L trial heads because they may not be compatible with the trial handles.

    Product
    Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0725-2014·2014-01-22

    GE Healthcare Recalls Mobile X-ray Systems Due to Software Display Issue

    GE Healthcare is recalling 1,027 Optima XR220amx and XR200amx mobile X-ray systems due to a software issue that may cause patient exams to display incorrectly.

    Product
    GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0756-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0753-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0758-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.

    Product
    MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions for use were unclear.

    Product
    MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0777-2014·2014-01-22

    SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues

    SpineFrontier, Inc. is recalling 23 Arena-L 35x26 Trial Heads because they may not be compatible with the trial handles.

    Product
    Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm…
    Category
    Medical Device
    Distribution
    1 state