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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Minimum severity

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

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15001–15025 of 39988

  • ModerateFDA (Devices)·Z-1189-2021·2021-03-17

    Physio-Control Recalls LIFEPAK CR2 Defibrillators Due to Missing Lid Magnets

    Physio-Control is recalling 89,763 LIFEPAK CR2 defibrillators because missing lid magnets may cause premature battery depletion.

    Product
    PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1188-2021·2021-03-17

    Siemens Dimension Vista HDLC Reagent Cartridges Recalled for Erroneous Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista HDLC reagent cartridges due to discolored reagents that may cause erroneous test results.

    Product
    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1184-2021·2021-03-17

    MedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size

    Medical Components, Inc. is recalling 96 Power Injectable CT Port kits because they contain 6.6F ports instead of the correct 5F size, which may prolong surgical procedures.

    Product
    Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1183-2021·2021-03-17

    OraSure Methamphetamine Test Kit Recalled for Incorrect Reagent Lot Labeling

    OraSure Technologies is recalling 16 units of Methamphetamine Intercept Microplate kits due to a labeling error where the wrong lot number was printed on the box.

    Product
    Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1156-2021·2021-03-10

    Hamilton Heater Shaker Recalled Due to Fire Risk from Flammable Liquids

    Hamilton Co is recalling 4,729 Heater Shaker units because flammable liquids entering the device can cause a fire.

    Product
    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1159-2021·2021-03-10

    ReNovo Recalls Reprocessed Medical Devices Shipped as Sterile

    ReNovo, Inc. is recalling 81 units of reprocessed medical devices that were shipped to customers labeled as sterile but were non-sterile.

    Product
    Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2021·2021-03-10

    BioFire Film Array BCID Panels Recalled for False Positive Risk

    BioFire Diagnostics is recalling Film Array BCID Panels due to an increased risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC vials.

    Product
    Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2021·2021-03-10

    United Imaging X-ray System Recalled for Uncommanded Motion Hazard

    Shanghai United Imaging Healthcare is recalling six X-ray systems because the tube head may move unexpectedly, posing a collision risk to patients.

    Product
    Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2021·2021-03-10

    BioFire BCID2 Panel Recalled for False Positive Pseudomonas Results

    BioFire Diagnostics is recalling BCID2 Panels due to a risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC blood culture vials.

    Product
    BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2021·2021-03-10

    Baxter Recalls PrisMax Hemodialysis Tubing Due to Performance Variability

    Baxter Healthcare is recalling PrisMax System Version II hemodialysis tubing due to performance variability that may cause alarms and therapy interruptions.

    Product
    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1161-2021·2021-03-10

    ACIST Kodama Intravascular Ultrasound Catheter Recalled for Damaged O-Ring

    Acist Medical Systems is recalling Kodama Intravascular Ultrasound Catheters because damaged o-ring fragments could be flushed out of the device.

    Product
    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2021·2021-03-10

    Siemens Sensis Vibe Systems Recalled for Potential System Freezes

    Siemens is recalling 37 Sensis Vibe systems in the US because they may sporadically freeze during operation or idle, preventing user interaction.

    Product
    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2021·2021-03-10

    Bovie Velocity Disposable Bipolar Ablators Recalled for Sterile Packaging Defect

    Bovie Medical Corporation is recalling Velocity Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.

    Product
    Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1170-2021·2021-03-10

    Boston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals

    Boston Scientific is recalling Captivator, Captiflex, and Sensation polypectomy snares because users reported incomplete pouch seals before use.

    Product
    Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M00560310; M00560321 (Box 5), M00560320; M00562651 (Box 5), M00562650; M00562652 (Box 20), M00562650; M00562671 (Box 5), M00562670…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1155-2021·2021-03-10

    Bovie Medical Recalls ConMed Disposable Bipolar Ablators Due to Packaging Defect

    Bovie Medical Corporation is recalling 5,270 ConMed Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.

    Product
    ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2021·2021-03-10

    G & H Wire Company Recalls Orthodontic Elastic Bands Due to Labeling Error

    G & H Wire Company is recalling orthodontic elastic bands because the patient pack text is incorrect, which could lead to misuse and temporary discomfort.

    Product
    Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1154-2021·2021-03-10

    Bovie Medical Recalls HNM Disposable Bipolar Ablators Due to Packaging Defect

    Bovie Medical Corporation is recalling 3,862 HNM Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the barrier.

    Product
    HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2021·2021-03-10

    Johnson & Johnson Recalls Nonconforming TECNIS Toric Intraocular Lenses

    Johnson & Johnson Surgical Vision Inc is recalling 27 TECNIS Toric 1-Piece Intraocular Lenses due to the release of nonconforming products.

    Product
    TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsular bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2021·2021-03-10

    CooperSurgical Recalls Milex Gellhorn Flexible Pessaries Due to Manufacturing Error

    CooperSurgical is recalling specific lots of Milex Gellhorn Flexible pessaries because they were manufactured with incorrect stem lengths.

    Product
    Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1162-2021·2021-03-10

    Nihon Kohden Telemetry Recalled for Incorrect Date Stamp or No Data Transfer

    Nihon Kohden America Inc is recalling WMTS Telemetry Receivers because they may display incorrect date stamps or fail to transfer data.

    Product
    WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-1172-2021·2021-03-10

    Barco Diagnostic Radiology Display Recalled for Lack of DICOM Compliance

    Barco N.V. is recalling MDNC-3421 diagnostic radiology displays because they were shipped without being DICOM-compliant. These units will not pass required acceptance tests.

    Product
    Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1168-2021·2021-03-10

    Boston Scientific Recalls Polypectomy Snares Due to Incomplete Pouch Seals

    Boston Scientific is recalling Captivator and Captiflex polypectomy snares because users reported incomplete pouch seals before patient use.

    Product
    Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1169-2021·2021-03-10

    Boston Scientific Recalls Captivator II Polypectomy Snares Due to Incomplete Seals

    Boston Scientific is recalling Captivator II Single-Use Polypectomy Snares because users reported incomplete pouch seals before use.

    Product
    Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2021·2021-03-03

    DeRoyal Recalls Non-Sterile Sternum Saw Blades in Surgical Packs

    DeRoyal Industries is recalling 309 CV Basin Set Packs because the included sternum saw blades are not sterile.

    Product
    CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states