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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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

39076–39100 of 40449

  • LowFDA (Devices)·Z-0683-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 670 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0680-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 5 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0684-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 2,711 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0649-2013·2013-01-16

    California Medical Laboratories Recalls Sterile Rigid Tip Suction Wands

    California Medical Laboratories is recalling sterile rigid tip suction wands because the distal tip may detach and fall into a patient's chest cavity during surgery.

    Product
    Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0650-2013·2013-01-16

    California Medical Laboratories Recalls Rigid Tip Suction Wands Due to Tip Detachment Risk

    California Medical Laboratories is recalling Rigid Tip Suction Wands because the distal tip may detach and fall into a patient's chest cavity during surgery.

    Product
    Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0659-2013·2013-01-16

    Zimmer Ardis Interbody System Inserter Recalled for Release Knob Issues

    Zimmer, Inc. is recalling 170 Ardis Interbody System Inserters because the release knob may be difficult to turn, potentially leaving the implant engaged in the patient.

    Product
    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0651-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0645-2013·2013-01-16

    Horiba Medical Recalls ABX PENTRA ML Software Due to Data Validation Error

    Horiba Medical is recalling ABX PENTRA ML software versions V8.0.x and below, V9.0.1, and V9.0.2 because a rare data management issue may transmit incorrect patient results to the Laboratory Information System.

    Product
    ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2013·2013-01-16

    Stryker Recalls Surgical Light Spring Arms Due to Potential Separation Risk

    Stryker is recalling specific surgical light spring arms because a circlip may not engage fully, causing the arm to fall. No serious injuries have been reported.

    Product
    (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2013·2013-01-16

    Concentric Medical Recalls FlowGate Balloon Guide Catheters Due to Tip Collapse

    Concentric Medical is recalling 13 FlowGate Balloon Guide Catheters after reports of resistance and possible distal tip collapse during use.

    Product
    FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0644-2013·2013-01-16

    Applied Medical Recalls Kii Shielded Bladed Access Systems Due to Blade Exposure Risk

    Applied Medical is voluntarily recalling 72 units of Kii shielded bladed access systems because the blade may remain exposed after shield deployment.

    Product
    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2013·2013-01-16

    Zoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops

    Zoll Circulation is recalling AutoPulse Model 100 systems because they may stop compressions unexpectedly during use.

    Product
    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0653-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network, Inc. recalled UltraFill DBM Putty-Porcine because products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0662-2013·2013-01-16

    Maquet Cardiosave Intra-Aortic Balloon Pump Recall for Cord Failure Risk

    Maquet is recalling 29 Cardiosave Intra-Aortic Balloon Pumps because the coiled cord assembly may fail if mishandled.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0663-2013·2013-01-16

    Merit Medical Recalls Custom Procedural Trays Due to Particulate Matter

    Merit Medical Systems is recalling 422 Custom Procedural Trays and Kits because of particulate matter found in the 0.9% Sodium Chloride Injection.

    Product
    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0660-2013·2013-01-16

    Biomet Recalls PT Hybrid Glenoid Post Due to Oversized Thread

    Biomet is recalling PT Hybrid Glenoid Posts because an oversized male thread may prevent the post from seating fully, potentially creating a gap in the implant.

    Product
    PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0643-2013·2013-01-16

    Philips HeartStart HS1 Defibrillators Recalled for Manual Clarification

    Philips is recalling HeartStart HS1 defibrillators to clarify maintenance information in the Owner's Manual.

    Product
    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2013·2013-01-16

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays due to higher imprecision and outliers on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0640-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Inaccurate Leukocyte Results

    Siemens Healthcare Diagnostics Inc is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2013·2013-01-16

    Siemens CLINITEK Atlas Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens is recalling CLINITEK Atlas Positive and Negative Control Strips because leukocyte results may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2013·2013-01-16

    Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Shelf-Life Data

    Advanced Sterilization Products is recalling 12,280 STERRAD NX Cassettes because it lacks adequate data to support the product's labeled shelf-life.

    Product
    STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2013·2013-01-16

    Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues

    Siemens Healthcare Diagnostics is recalling specific lots of TSH calibrator vials because they showed under-recovery of dose values.

    Product
    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0637-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2013·2013-01-16

    Stryker Recalls Accolade Hip Stems Due to Packaging Mix-Up

    Stryker is recalling specific Accolade hip stems because size 3.5 stems were mistakenly packaged as size 2.5 stems, creating a risk of product mix-up.

    Product
    Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide