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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23626–23650 of 27699

  • HighFDA (Devices)·Z-1382-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Camera Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1384-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Monitor Drapes Due to Waxy Appearance

    Intuitive Surgical is recalling da Vinci S Vision-Cart Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

    Product
    da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1381-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Camera Arm Drapes

    Intuitive Surgical is recalling da Vinci S Camera Arm Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1362-2015·2015-04-08

    Pega Medical Recalls GAP Nail 4.8mm Due to Distal Screw Hole Failures

    Pega Medical Inc. is recalling 7 units of the 4.8mm GAP Nail because of failures at the distal cortical screw holes, primarily in patients with specific bone conditions.

    Product
    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1356-2015·2015-04-08

    Medtronic Temporary Pacemaker Recalled for Battery Connection Failure

    Medtronic is recalling 6,040 Model 5392 temporary pacemakers because specific AA batteries may fail to connect, potentially stopping pacing therapy.

    Product
    Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1370-2015·2015-04-08

    BD FACSCalibur Instruments Recalled for Incorrect Circuit Breaker Amperage

    BD Biosciences is recalling 72 BD FACSCalibur instruments because some have circuit breakers with incorrect amperage ratings, which may fail to open during over-current situations.

    Product
    BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1357-2015·2015-04-08

    DePuy RECLAIM Hip Implant Inserter Adaptor Recalled for Fracture Risk

    DePuy Orthopaedics is recalling 54 units of the RECLAIM Assembled Implant Inserter Adaptor because the instrument may fracture during surgery, potentially leaving plastic pieces in the patient.

    Product
    RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1355-2015·2015-04-08

    Boston Scientific Recalls Biliary Drainage Catheters Due to Fragmentation Risk

    Boston Scientific is recalling specific lots of Expel Drainage Catheters because they may fragment after implantation, potentially requiring additional medical procedures to remove the pieces.

    Product
    Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1364-2015·2015-04-08

    Biomet Recalls Ziploop Button and ToggleLocs Due to Packaging Seal Issues

    Biomet, Inc. is recalling 50 units of Ziploop Buttons and ToggleLocs manufactured in 2014 because sterile packaging was not properly sealed.

    Product
    Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2015·2015-04-08

    Medcomp Recalls Catheter Insertion Kits Due to Sterilization Defect

    Medcomp is recalling specific catheter insertion kits because one biological indicator failed during the sterilization process, potentially compromising sterility.

    Product
    Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1341-2015·2015-04-08

    Microtek Medical Recalls Laparoscopic Tubing Sets Due to Unlabeled Latex Packaging

    Microtek Medical Inc. is recalling 270 units of sterile laparoscopic tubing sets because the packaging contains latex but lacks the required warning label.

    Product
    LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2015·2015-04-08

    Edwards Lifesciences Recalls Fem-Flex II Pediatric Femoral Arterial Cannulas

    Edwards Lifesciences is recalling specific sizes of the Fem-Flex II Pediatric Femoral Arterial Cannula due to a protruding wire at the tip that could cause tissue damage.

    Product
    Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2015·2015-04-08

    Microtek Medical Recalls Surgical Helmet Motor Modules for Latex Packaging

    Microtek Medical Inc is recalling 38 units of FREEDOMAIRE Motor Modules because the packaging contains latex but lacks the required warning label.

    Product
    FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2015·2015-04-08

    Microtek Medical Smoke Evacuator Tubing Set Recalled for Latex Packaging

    Microtek Medical is recalling smoke evacuator tubing sets because the packaging contains latex but lacks the required warning label.

    Product
    TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or power tool surgical procedures. Locations include…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2015·2015-04-08

    Roche Recalls Accu-Chek Connect App Due to Inaccurate Bolus Advice

    Roche Diabetes Care is recalling the Accu-Chek Connect app because a screen orientation change may cause it to provide inaccurate bolus advice to users.

    Product
    ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1376-2015·2015-04-08

    GE Healthcare Recalls Aespire Anesthesia Machines Due to Circuit Board Failure

    GE Healthcare is recalling 46 Aespire 7900 and Aespire View anesthesia machines because a CPU circuit board defect may cause a blank display or loss of mechanical ventilation.

    Product
    GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1336-2015·2015-04-08

    Boston Scientific Recalls Expel Drainage Catheters Due to Fragmentation Risk

    Boston Scientific is recalling Expel APD and APDL Drainage Catheters after one report of device fragmentation in the biliary system.

    Product
    Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1363-2015·2015-04-08

    Biomet Recalls ToggleLoc and Ziploop Fixation Devices Due to Packaging Defects

    Biomet is recalling ToggleLoc and Ziploop devices manufactured in 2014 because sterile packaging was not sealed, potentially compromising sterility.

    Product
    ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2015·2015-04-08

    Leonhard Lang ECG Electrodes Recalled for Signal Transmission Failure

    Leonhard Lang is recalling specific lots of Skintact and Stable Base ECG electrodes because they may fail to transmit signals.

    Product
    Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1307-2015·2015-04-01

    Philips Recalls Lithium Polymer Fiber Optic Module Batteries Due to Ignition Risk

    Philips Medical Systems is recalling 79 lithium polymer fiber optic module batteries used in Intera MR Systems because a battery ignited during recharging.

    Product
    Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring…
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1290-2015·2015-04-01

    Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy System

    Cardiovascular Systems, Inc. is recalling 30 units of the Diamondback 360 Coronary Orbital Atherectomy System because the outer layer may flake off, potentially causing a flow-limiting embolism.

    Product
    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1324-2015·2015-04-01

    Titan Spine Recalls TCS Straight Hexalobe Drivers Due to Tip Shearing

    Titan Spine, LLC is recalling 26 Endo TCS Driver Straight Hexalobe #6 units because the tips sheared off during use in patients with dense bones.

    Product
    Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1326-2015·2015-04-01

    Ameda One-Hand Manual Breast Pump Recalled for Lack of Sterilization

    Ameda, Inc. is recalling 1,763 units of the One-Hand Manual Breast Pump (SKU 17161) because the devices were not sterilized.

    Product
    Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2015·2015-04-01

    GE Healthcare Recalls MRI Systems Due to Software Maintenance Issues

    GE Healthcare is recalling 9,369 MRI systems worldwide because software versions were not maintained properly at some sites.

    Product
    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2015·2015-04-01

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault

    Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide because a fault causes distal SUJ failures and position sensor mismatches.

    Product
    da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive…
    Category
    Medical Device
    Distribution
    Distributed nationwide