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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25126–25150 of 40357

  • HighFDA (Devices)·Z-0516-2018·2018-02-14

    Zimmer Biomet Recalls 1.0mm Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 1,524 non-sterile 1.0mm drill bits because a raw material anomaly may increase the risk of instrument fracture.

    Product
    DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0514-2018·2018-02-14

    Philips Precedence 16 Imaging System Recalled for Collimator Drop Risk

    Philips is recalling 1,387 Precedence 16 imaging systems because collimators may drop to the floor during exchange, posing a physical hazard.

    Product
    Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0518-2018·2018-02-14

    Philips Brilliance 64 CT System Recalled for Software Issues

    Philips Medical Systems is recalling 1,801 Brilliance 64 CT systems due to software issues in version 4.1.6.

    Product
    Philips Brilliance 64 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0525-2018·2018-02-14

    ConvaTec Recalls Mislabelled Ostomy Skin Barrier Products

    ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.

    Product
    SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0533-2018·2018-02-14

    MedComp Recalls CT Port Kits Packaged With Incorrect Needle Size

    Medical Components, Inc. is recalling 65 units of CT Port kits that were packaged with 21G needles instead of the labeled 18G needles.

    Product
    6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0548-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification Gap

    Zimmer Biomet is recalling 1,517 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm lengths.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2018·2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.25 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0555-2018·2018-02-14

    Cyberonics Recalls Two VNS Therapy Programmer Units Distributed Before Approval

    Cyberonics, Inc. is recalling two VNS Therapy Programmer units that were distributed in error before FDA approval of the specific software version.

    Product
    VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0522-2018·2018-02-14

    Philips Ingenuity TF PET/CT Recalled for Missing Gantry Mounting Hardware

    Philips is recalling two Ingenuity TF PET/CT systems because one wire channel inside the Gantry Separation Unit was missing mounting hardware.

    Product
    Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0543-2018·2018-02-14

    Busse Bone Marrow Biopsy Tray Recalled for Foreign Matter

    Robert Busse & Co. is recalling 5 cases of Safety Deluxe Bone Marrow Biopsy/Aspiration Trays due to the presence of loose polypropylene foreign matter.

    Product
    Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0515-2018·2018-02-14

    Siemens ADVIA Centaur Calibrator 30 Recalled for Negative Bias

    Siemens is recalling ADVIA Centaur Calibrator 30 kits because they cause negative bias in Estradiol tests on specific systems.

    Product
    ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0550-2018·2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 10,116 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2018·2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.50 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0529-2018·2018-02-14

    Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators

    Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.

    Product
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2018·2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 1,631 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0538-2018·2018-02-14

    Exactech Recalls Alteon HA Femoral Stems Due to Labeling Error

    Exactech is recalling 34 Alteon HA Femoral Stems because the labels incorrectly described the device. The units were distributed to five US states.

    Product
    Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0519-2018·2018-02-14

    Philips Ingenuity Core CT System Software Recall

    Philips Medical Systems is recalling Ingenuity Core CT systems due to software issues in Brilliance iCT 4.1.6.

    Product
    Philips Ingenuity Core computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0552-2018·2018-02-14

    3M Recalls ACE Ultra Lite Ankle Braces Due to Mold Contamination

    3M is recalling specific sizes of ACE Ultra Lite Ankle Braces because mold was found on non-patient contact surfaces. The mold was identified as Aspergillus candidus.

    Product
    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-0542-2018·2018-02-14

    Busse Lumbar Puncture Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Safety-Deluxe Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0521-2018·2018-02-14

    Philips Ingenuity CT System Recalled for Software Issues

    Philips Medical Systems is recalling Ingenuity CT systems due to software issues in version 4.1.6. The recall affects 26 US government accounts.

    Product
    Philips Ingenuity CT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0537-2018·2018-02-14

    Medtronic Ascenda Intrathecal Catheter Recall for Kinking Risk

    Medtronic is recalling specific lots of Ascenda Intrathecal Catheters due to a potential risk of kinking at the proximal end where the catheter connects to the drug infusion pump.

    Product
    Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0545-2018·2018-02-14

    Busse Lumbar Puncture Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification

    Zimmer Biomet is recalling 6,290 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2018·2018-02-14

    Busse Laceration Tray Recall Due to Foreign Matter

    Busse Hospital Disposables is recalling Laceration Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0540-2018·2018-02-14

    Busse Lumbar Puncture Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Safety-Deluxe Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide