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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32476–32500 of 40449

  • ModerateFDA (Devices)·Z-2296-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 103 G1 dissection tools because the specified shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2239-2015·2015-08-05

    EXP Recalls Unregistered Medical Device Exchange Round Diamond Bur

    EXP Pharmaceutical Services Corp is recalling Round Diamond Bur Extra Coarse devices because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2227-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Implantable Skin Staple Systems

    EXP Pharmaceutical Services Corp is recalling three units of implantable skin staple systems because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2248-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging Operations

    EXP Pharmaceutical Services Corp is recalling 12x40 Airway Stent Systems due to failure to register as a medical device establishment and lack of a quality system.

    Product
    Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2306-2015·2015-08-05

    Anspach Effort Recalls G1 Dissection Tools Due to Labeling Inconsistencies

    The Anspach Effort, Inc. is recalling 796 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.

    Product
    ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2282-2015·2015-08-05

    Anspach Extra Coarse Diamond Drum Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 88 Extra Coarse Diamond Drums because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2214-2015·2015-08-05

    EXP Recalls 5.5mm BioComposite Corkscrew Suture Anchor Due to Registration Failure

    EXP Pharmaceutical Services Corp is recalling 5.5mm BioComposite Corkscrew Suture Anchors because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2222-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Mayfield Disposable Skull Pins

    EXP Pharmaceutical Services Corp is recalling Mayfield Disposable Skull Pins because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2266-2015·2015-08-05

    Philips Invivo Expression MRI Patient Monitoring System Labeling Recall

    Philips is recalling 697 MRI patient monitoring systems because the labeling inaccurately lists endotracheal as a valid body temperature application site for the FlexTEMP sensor.

    Product
    Invivo Expression MRI Patient Monitoring System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2285-2015·2015-08-05

    Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 115 fluted drum dissection tools because the specified shaft exposure may be inconsistent with certain attachments, potentially resulting in greater exposure than labeled.

    Product
    ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2232-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Laparoscopic Insufflation Needles

    EXP Pharmaceutical Services Corp is recalling two units of laparoscopic insufflation needles due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2212-2015·2015-08-05

    EXP Pharmaceutical Services Recalls GelPort Laparoscopic Systems for Registration Violations

    EXP Pharmaceutical Services Corp is recalling three GelPort Laparoscopic Systems because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2251-2015·2015-08-05

    EXP Recalls Chocolate Balloon Catheters Due to Registration Deficiencies

    EXP Pharmaceutical Services Corp is recalling one unit of a Chocolate Balloon Catheter because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2274-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Clinical Culture Media Due to Lack of Clearance

    Hardy Diagnostics is recalling several clinical culture media products, including BHI with Ciprofloxacin, because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2015·2015-08-05

    EXP recalls Stryker Round Fluted Burs due to registration violations

    EXP Pharmaceutical Services Corp is recalling Stryker Round Fluted Burs because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2226-2015·2015-08-05

    EXP Recalls Unregistered Implantable Clips Due to Regulatory Non-Compliance

    EXP Pharmaceutical Services Corp is recalling 17 units of implantable clips because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2229-2015·2015-08-05

    EXP Recalls ETS FLEX 45 Endoscopic Articulating Linear Cutters

    EXP Pharmaceutical Services Corp is recalling ETS FLEX 45 endoscopic cutters because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2247-2015·2015-08-05

    EXP Recalls Unregistered Surgical Routers for Crani-A Procedures

    EXP Pharmaceutical Services Corp is recalling four surgical routers because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2304-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 78 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.

    Product
    ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2237-2015·2015-08-05

    EXP Pharmaceutical Services Recalls Sterile Nonabsorbable Sutures and Sternotomy Wires

    EXP Pharmaceutical Services Corp is recalling 19 units of sterile nonabsorbable sutures and sternotomy wires due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2254-2015·2015-08-05

    Philips Brilliance CT 64-Channel Systems Recalled for Software Defects

    Philips is recalling four Brilliance CT 64-channel systems due to software errors affecting image quality, dose control, and heart rate measurements.

    Product
    Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2322-2015·2015-08-05

    Acon Recalls Mission Breath Alcohol Detector Kits for Labeling Amendment

    Acon Laboratories is recalling 1,283 Mission Breath Alcohol Detector kits due to a labeling amendment. The devices are distributed nationwide.

    Product
    Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2276-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiological Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.

    Product
    Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2279-2015·2015-08-05

    Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.

    Product
    Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2240-2015·2015-08-05

    EXP Recalls 6.0mm Round Fluted Bur Due to Registration Deficiencies

    EXP Pharmaceutical Services Corp is recalling 5 units of 6.0mm Round Fluted Bur Soft Touch because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Medical Device
    Distribution
    6 states