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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14776–14800 of 27500

  • HighFDA (Devices)·Z-0354-2020·2019-11-20

    Monarch Medical Technologies Recalls EndoTool SubQ Software Versions

    Monarch Medical Technologies is recalling EndoTool SubQ software versions 1.7.1, 1.7.4, and 1.7.5 because the product was distributed prior to FDA approval or clearance.

    Product
    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0396-2020·2019-11-20

    Orthofix Pelvis Sterile Kit Recalled for Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Pelvis Sterile Kits because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0350-2020·2019-11-20

    PrivaPath Universal Sexual Health Testing Kit Recalled for Damaged Tubes

    PrivaPath Diagnostics is recalling Universal Sexual Health Testing Kits due to potential tube damage that may cause blood exposure or erroneous results.

    Product
    Universal Sexual Health Testing Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2020·2019-11-20

    Cadence Science Pressure Control Glass Syringes Recalled for Breakage Risk

    Cadence Science is recalling 237 Pressure Control Glass Syringes because they may break during use, posing a potential injury risk to patients and healthcare workers.

    Product
    Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0279-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0278-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0216-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Falling Detector Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall vertically to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0172-2020·2019-11-13

    Medtech Rosa Brain 3.0 Neurosurgical Device Recalled for Trajectory Errors

    Medtech SAS is recalling 93 Rosa Brain 3.0 neurosurgical devices because the instrument holder may send tools on incorrect trajectories, potentially leading to improper device placement.

    Product
    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0276-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

    Baxter Healthcare is recalling Prismaflex Control Units with software versions below 7.21 because communication error alarms may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0277-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Potential Therapy Interruption

    Baxter Healthcare is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0345-2020·2019-11-13

    Abiomed lmpella CP Pump Recalled for Incorrect Programming and Disabled Alarms

    Abiomed is recalling one lmpella CP pump with Smart Assist due to incorrect programming that disabled safety alarms and altered pump operation.

    Product
    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0215-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Detector Fall Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0281-2020·2019-11-13

    GE Healthcare Recalls Giraffe OmniBed Carestation CS1 Due to Fastener Risk

    GE Healthcare is recalling 59 Giraffe OmniBed Carestation CS1 devices because fasteners may be under-torqued, posing a risk that the canopy could detach and fall.

    Product
    Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2020·2019-11-13

    Zimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion

    Zimmer Biomet is recalling 5.4 million custom medical devices because non-highly polished implants may adhere to the LDPE bag packaging.

    Product
    Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2020·2019-11-13

    Argon Medical Devices Recalls Sterile Adapters Due to Seal Defects

    Argon Medical Devices is recalling specific lots of sterile double female and male luer lock adapters because incomplete pouch seals may compromise sterility.

    Product
    (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2020·2019-11-13

    Insulet Recalls Omnipod DASH Insulin Systems Due to Communication Interruption

    Insulet Corporation is recalling 264 units of the Omnipod DASH Insulin Management System because a communication interruption may cause inaccurate insulin data to be displayed.

    Product
    Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2020·2019-11-13

    Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

    Western / Scott Fetzer is recalling 486 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2020·2019-11-13

    Teleflex Recalls Babi.Plus Pressure Relief Manifolds for Ventilators

    Teleflex is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because the devices vented gas below the stated pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2020·2019-11-13

    Medtronic Recalls MiniMed Model 500 Remote Controls for Security Vulnerability

    Medtronic is recalling MiniMed Model 500 Remote Controls used with the MiniMed 508 Insulin Pump due to a potential security vulnerability.

    Product
    Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0273-2020·2019-11-13

    Thermo Fisher Recalls Cardinal Health Specimen Containers Due to Plastic Shavings

    Thermo Fisher Scientific is recalling Cardinal Health specimen containers that may contain plastic shavings on threaded surfaces.

    Product
    Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0217-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled Due to Detector Falling Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2020·2019-11-13

    Philips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 6,790 Grab n Go Opti series VIPR systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2020·2019-11-13

    Argon Medical Devices Recalls AHD Luer Lock Caps Due to Seal Defect

    Argon Medical Devices is recalling 49,130 AHD Luer Lock Caps because an incomplete seal may cause loss of sterility.

    Product
    Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide