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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33251–33275 of 40325

  • 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
  • ModerateFDA (Devices)·Z-1372-2015·2015-04-08

    Biologic Therapies Recalls Bio-PLASTY Cannulas for Misbranding

    Biologic Therapies, Inc. is recalling 58 Bio-PLASTY Cannulas because they were distributed without proper FDA clearance and classification.

    Product
    Bio-PLASTY Cannula (Needle)
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1359-2015·2015-04-08

    Philips CT Systems Recalled for Inverted Scan Position Software Defect

    Philips is recalling 424 CT systems worldwide because a software defect inverts the sign of the longitudinal position for some scans.

    Product
    Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1368-2015·2015-04-08

    Quest Medical Recalls Lacrimal Intubation Sets Due to Labeling Error

    Quest Medical is recalling 106 units of LIS27T Lacrimal Intubation Sets because the expiration date was incorrectly printed in the manufacturing date field.

    Product
    LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1348-2015·2015-04-08

    Microtek Medical Recalls Sterile Laser Resistant Wands Due to Latex Packaging

    Microtek Medical Inc is recalling sterile laser resistant wands because the packaging contains latex but lacks the required warning label.

    Product
    LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, 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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1337-2015·2015-04-08

    Microtek Medical Recalls Freedomaire Surgical Helmet Systems Due to Latex Packaging

    Microtek Medical is recalling 10 Freedomaire Surgical Helmet Systems because the packaging contains latex but lacks the required warning label.

    Product
    FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2015·2015-04-08

    Microtek Smoke Evacuation Tubing Set Recalled for Latex Packaging Labeling Error

    Microtek Medical Inc is recalling 303 Smoke Evacuation Tubing Sets because the packaging contains latex but lacks the required warning label.

    Product
    Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1347-2015·2015-04-08

    Microtek Medical Smoke Evacuator Tube Sets Recalled for Latex Packaging

    Microtek Medical Inc is recalling sterile smoke evacuator tube sets because the packaging contains latex without the required warning label.

    Product
    (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX 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
  • ModerateFDA (Devices)·Z-1375-2015·2015-04-08

    BD Biosciences Recalls CD123 PE Reagent Due to Antibody Contamination

    BD Biosciences is recalling one lot of CD123 PE reagent because it contains a low amount of CD4 antibody, which may result in unexpected staining patterns.

    Product
    CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1360-2015·2015-04-08

    Zimmer Recalls Persona Anterior Referencing Sizers Due to Specification Nonconformance

    Zimmer, Inc. is voluntarily recalling 22 lots of Persona Anterior Referencing Sizers with Locking Boom because the devices do not conform to print specifications.

    Product
    Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer…
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1361-2015·2015-04-08

    King Systems Double Swivel Connector Recalled for Mislabeling

    King Systems Corp. is recalling 900 units of Double Swivel Connectors mislabeled as having a suction port. The error may cause a short procedure delay but poses no risk to patients.

    Product
    Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2015·2015-04-08

    Microtek Medical Smoke Evacuator Tubing Recalled for Unlabeled Latex Packaging

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

    Product
    TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\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 procedures. Locations include Operating Rooms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2015·2015-04-08

    Biologic Therapies Recalls Bio-CORE Cannula Sets for Misbranding

    Biologic Therapies, Inc. is recalling Bio-CORE Cannula (Needle) Sets because they were distributed without proper FDA clearance and classification.

    Product
    Bio-CORE Cannula (Needle) Set
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1366-2015·2015-04-08

    Owen Mumford Autoject E1 Fixed Needle Device Recalled for Missing Components

    Owen Mumford USA, Inc. is recalling 3,100 Autoject E1 Fixed needle devices because the syringe carrier is missing a damper and spring.

    Product
    Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1353-2015·2015-04-08

    Stryker Recalls Vitagel Surgical Hemostat Due to Cold Chain Violations

    Stryker Orthobiologics is recalling Vitagel surgical hemostat shipments that were not delivered within validated timeframes, potentially compromising the product's required cold storage.

    Product
    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide