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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23551–23575 of 27663

  • HighFDA (Devices)·Z-1442-2015·2015-04-22

    Baylis Medical Recalls ProTrack Microcatheter Due to Circumferential Shaft Defects

    Baylis Medical Corp is recalling two lots of ProTrack Microcatheters due to potential circumferential defects along the device shaft.

    Product
    ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2015·2015-04-22

    Bard PICC and Dialysis Catheter Kits Recalled for Scalpel Injury Risk

    Bard Access Systems is recalling PICC and dialysis catheter kits containing Safe-Cut Safety Scalpels due to the potential for inadvertent scalpel stick injuries.

    Product
    Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2015·2015-04-22

    US Endoscopy Recalls Talon Grasping Devices Due to Detached Wire Component

    US Endoscopy Group Inc is recalling 1,695 Talon Grasping Devices because a wire component on the distal grasping assembly became detached.

    Product
    Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1447-2015·2015-04-22

    Bard Monopty Disposable Core Biopsy Instruments Recalled for Activation Issues

    Bard Peripheral Vascular is recalling specific Bard Monopty Disposable Core Biopsy Instruments and Kits due to potential activation-related issues.

    Product
    Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2015·2015-04-22

    CooperSurgical Recalls Wallach LL 100 Cryosurgical Units Due to Gas Line Burst Risk

    CooperSurgical is recalling 255 Wallach LL 100 cryosurgical units because an internal gas line may malfunction and burst under pressure.

    Product
    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2015·2015-04-22

    Bard ConQuest PTA Balloon Dilatation Catheter Recalled for Deflation Risk

    Bard Peripheral Vascular is recalling specific lots of the ConQuest PTA Balloon Dilatation Catheter due to a risk of deflation-related issues.

    Product
    Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1328-2015·2015-04-15

    Lusys Laboratories Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1334-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1329-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1335-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1331-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One-Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1377-2015·2015-04-15

    Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent

    Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.

    Product
    CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic…
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-1330-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One-Step Test Kits

    Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1332-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1333-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1404-2015·2015-04-15

    Teleflex Medical Recalls Pluer-evac Sahara Chest Drainage Systems

    Teleflex Medical is recalling 2,148 adult-sized Pluer-evac Sahara Chest Drainage Systems because they contain infant-sized components.

    Product
    Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1392-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 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-1386-2015·2015-04-15

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

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

    Product
    da Vinci Si Surgical System IS3000, 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-1389-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a potential for the drape to tear.

    Product
    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 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-1400-2015·2015-04-15

    Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks

    Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.

    Product
    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1393-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 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-1390-2015·2015-04-15

    Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits

    Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.

    Product
    da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 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-1398-2015·2015-04-15

    Siemens QuikLYTE Dilution Check Recalled for Potential Result Bias

    Siemens Healthcare Diagnostics is recalling QuikLYTE Dilution Check units due to a potential positive bias that could cause elevated patient results for sodium, potassium, and chloride.

    Product
    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1397-2015·2015-04-15

    CooperSurgical Infant Transport Mattress Recalled for Missing Expiration Date

    CooperSurgical is recalling TransWarmer Infant Transport Mattresses because they lack expiration dates, potentially failing to meet specifications.

    Product
    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2015·2015-04-15

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

    Intuitive Surgical is recalling da Vinci S Surgical System arm drapes due to a cloudy, waxy appearance that may transfer to patients or cause tearing.

    Product
    da Vinci S Surgical System IS2000, 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