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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38751–38775 of 40449

  • ModerateFDA (Devices)·Z-1023-2013·2013-04-03

    Biosense Webster Recalls 20-Pole Eco Cable Due to Calibration Error

    Biosense Webster is recalling 54 units of the 20-Pole Eco Cable because incorrect calibration prevents the connected catheter from being recognized by the system.

    Product
    20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0975-2013·2013-04-03

    Orthohelix Intraosseous Fixation System Drill Bits Recalled for Manufacturing Defect

    Orthohelix Surgical Designs Inc is recalling specific lots of Intraosseous Fixation System drill bits because a burr prevents them from fitting over the guide wire.

    Product
    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1022-2013·2013-04-03

    Genetic Testing Institute Recalls PF4 Enhanced Assay Kits Due to Invalid Results

    Genetic Testing Institute is recalling 386 lots of LIFECODES PF4 Enhanced assay kits because inconsistent values can lead to invalid test results.

    Product
    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2013·2013-04-03

    Cardinal Health Recalls Needle Counters Due to Packaging Sterility Concerns

    Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0982-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0987-2013·2013-04-03

    Abbott Recalls ARCHITECT HBsAg Assay Files Due to Unauthorized Website Availability

    Abbott is recalling ARCHITECT HBsAg assay files because they were mistakenly made available on its website and via AbbottLink notifications.

    Product
    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1018-2013·2013-04-03

    Cooper Surgical Recalls Omniflex Diaphragms Due to Packaging Labeling Error

    Cooper Surgical is recalling 80 Omniflex Diaphragms because the incorrect size was printed on the outer packaging.

    Product
    Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-1011-2013·2013-04-03

    Cooper Surgical Cube Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 70 units of Cube Pessaries because the outer packaging may not reflect the actual size of the product inside.

    Product
    Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0988-2013·2013-04-03

    Siemens Dimension Vista Alkaline Phosphatase Calibrator Recalled for Accuracy Shift

    Siemens Healthcare Diagnostics is recalling 1,985 cartons of Dimension Vista Alkaline Phosphatase Calibrators due to correlation slope bias and accuracy shift.

    Product
    Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1009-2013·2013-04-03

    Cooper Surgical Gellhorn Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not reflect the actual size of the device inside.

    Product
    Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1004-2013·2013-04-03

    Cooper Surgical Incontinence Ring Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 80 units of Incontinence Ring Flexible Pessaries because the outer packaging may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1005-2013·2013-04-03

    Cooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 18 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1010-2013·2013-04-03

    Cooper Surgical Gellhorn Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling Gellhorn Flexible Pessaries because the outer packaging may not accurately reflect the size of the product inside.

    Product
    Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1007-2013·2013-04-03

    Cooper Surgical Incontinence Dish Folding Pessary Mislabeled Size Recall

    Cooper Surgical is recalling Incontinence Dish Folding Pessaries because the outer package may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1012-2013·2013-04-03

    Cooper Surgical Cube Pessary Recalled Due to Mislabeled Outer Packaging

    Cooper Surgical is recalling 20 units of Cube Pessaries because the outer packaging may not reflect the actual product size.

    Product
    Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1006-2013·2013-04-03

    Cooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 45 units of Incontinence Dish pessaries because the outer package may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1008-2013·2013-04-03

    Cooper Surgical Incontinence Pessary Recalled for Mislabeled Outer Packaging

    Cooper Surgical is recalling 31 units of Incontinence Dish Folding Pessaries because the outer packaging may not reflect the actual product size.

    Product
    Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1001-2013·2013-04-03

    CareFusion Recalls Preoperative Skin Prep Products Due to Sterility Labeling Error

    CareFusion is recalling Sepp Compound Benzoin Tincture products because labeling incorrectly implies the antiseptic solution is sterile, when only the applicator is sterile.

    Product
    Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0968-2013·2013-03-27

    Spacelabs Anesthesia Workstation Recall for Carbon Dioxide Defect

    Del Mar Reynolds Medical is recalling Spacelabs anesthesia workstations and service kits containing CAS I/II Absorbers due to a defect that may increase carbon dioxide levels in patient gas.

    Product
    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0971-2013·2013-03-27

    DePuy Specialist 2 IM Rod Recalled for Potential Breakage Risk

    DePuy Orthopaedics is recalling Specialist 2 IM Rods and associated surgical techniques due to a potential risk of the rod breaking and leaving fragments in patients.

    Product
    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0955-2013·2013-03-27

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions, Inc. is recalling Guardian II and Guardian II NC Hemostasis Valves used in cardiopulmonary bypass because air may be introduced into the device, potentially leading to an air embolism.

    Product
    Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions…
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-0953-2013·2013-03-27

    Exactech Recalls Knee Prosthesis Spacers Due to Dimensional Mismatch

    Exactech is recalling 123 Optetrak Logic knee prosthesis spacers and screws because a dimensional mismatch could allow interference between devices.

    Product
    Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0965-2013·2013-03-27

    Boston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation

    Boston Scientific is recalling SQ-RX Model 1010 subcutaneous pulse generators because an internal fuse may activate unintentionally, preventing the device from delivering therapy.

    Product
    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0961-2013·2013-03-27

    DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk

    DePuy Spine is recalling 549 CONFIDENCE Spinal Cement System kits because the cement mixer may jam or fail to turn properly during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide