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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18551–18575 of 27682

  • HighFDA (Devices)·Z-0946-2018·2018-03-21

    3M Recalls Ankle Braces Due to Missing Latex Warning Label

    3M is recalling specific ACE and Futuro ankle braces because they contain natural latex rubber but lack the required caution statement.

    Product
    ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0942-2018·2018-03-21

    Draeger Infinity Dual Hemo MCable Pod Recall for Liquid Ingress Risk

    Draeger Medical Systems is recalling 2,760 Dual Hemo MCable Pods (Revisions 15 and 16) because they may allow liquid ingress, potentially causing incorrect invasive blood pressure readings.

    Product
    INFINITY DUAL HEMO MCable Pod
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1067-2018·2018-03-21

    Diagnostica Stago Recalls Neoplastine Cl Plus Reagent Due to Homogeneity Defect

    Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a defect may cause inaccurate prothrombin time test results.

    Product
    Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1014-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2018·2018-03-21

    Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching

    Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers, creating a risk of using the wrong implant size.

    Product
    Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2018·2018-03-21

    Brainlab ExacTrac Software Recall for Beam Authorization Misinterpretation Risk

    Brainlab AG is recalling ExacTrac Patient Positioning System software versions 6.0 through 6.5 due to a risk of misinterpreting beam authorization when used with specific Varian accelerators.

    Product
    ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0988-2018·2018-03-21

    Alden HP54 Toric Contact Lenses Recalled for Sterility Assurance Issues

    Alden Optical is recalling HP54 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2018·2018-03-21

    Medtronic Recalls Unsterilized Acute Dual Lumen Dialysis Catheters

    Medtronic is voluntarily recalling one lot of MAHURKAR Elite Acute Dual Lumen Dialysis Catheters because they were distributed without being sterilized.

    Product
    MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0971-2018·2018-03-21

    Baxter SIGMA Spectrum Infusion Pump Recall for Pumping Mechanism Wear

    Baxter is recalling SIGMA Spectrum Infusion Pumps because excessive wear in the pumping mechanism may cause over- or under-infusion of fluids.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1017-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2018·2018-03-21

    Alden HP49 Toric Contact Lenses Recalled for Sterility Assurance Issues

    Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.

    Product
    Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2018·2018-03-21

    Smiths Medical Recalls Misassembled Power PORT-A-CATH II Implantable Port Kits

    Smiths Medical ASD Inc. is recalling 1,077 units of Power PORT-A-CATH II kits that may contain incorrect introducer sizes or locking collars.

    Product
    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific Versus hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1070-2018·2018-03-21

    Stanbio Recalls RaPET RF Latex Reagent Due to False Positive Test Results

    Stanbio Laboratory is recalling RaPET RF Latex Reagent because it causes all patient serum samples to yield weakly positive test results.

    Product
    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2018·2018-03-21

    Zimmer Biomet Recalls Nondegradable Soft Tissue Fixation Fasteners

    Zimmer Biomet is recalling 429 units of nondegradable soft tissue fixation fasteners because the implant shaft may shift and fall out during device opening.

    Product
    fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0977-2018·2018-03-21

    ZOLL Adult Defibrillator Electrodes Recall for Pediatric Energy Delivery Risk

    ZOLL Medical is recalling specific adult defibrillator electrodes that may cause R Series devices to deliver pediatric energy levels instead of adult levels.

    Product
    OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) Product Usage: Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2018·2018-03-21

    Diagnostica Stago Recalls Neoplastine Cl Plus Prothrombin Time Reagent Kits

    Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing inaccurate prothrombin time test results.

    Product
    Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0989-2018·2018-03-21

    Alden Classic 55 Toric Contact Lenses Recalled for Sterility Issues

    Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2018·2018-03-21

    BD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Additive Deficiency

    Becton Dickinson is recalling specific lots of BD Vacutainer K2 EDTA blood collection tubes because they may contain insufficient anticoagulant, potentially causing erroneous test results.

    Product
    BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2018·2018-03-14

    FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error

    The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.

    Product
    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0909-2018·2018-03-14

    Roche cobas 6000 Modular Series System Warning Added to Prevent Operator Injury

    Roche Diagnostics is adding a warning to cobas 6000 and 8000 Modular Series Operator Manuals to prevent operator injury during maintenance.

    Product
    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0922-2018·2018-03-14

    Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results

    Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.

    Product
    ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.

    Product
    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2018·2018-03-14

    Abbott Recalls ARCHITECT c16000 Cuvette Segments Due to Falsely Depressed Results

    Abbott Laboratories is recalling cuvette segments for the ARCHITECT Clinical Chemistry system because detached segment posts may cause falsely depressed patient test results.

    Product
    ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15…
    Category
    Medical Device
    Distribution
    Distributed nationwide