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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19001–19025 of 40124

  • ModerateFDA (Devices)·Z-0379-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0405-2020·2019-11-20

    Tornier Recalls Aequalis Ascend Flex Humeral Stems Due to Packaging Material Transfer

    Tornier, Inc. is recalling 87,869 Aequalis Ascend Flex Humeral Stems because movement during shipping may cause PETG material from the packaging to transfer to the device.

    Product
    Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0403-2020·2019-11-20

    Orthofix Galaxy Wrist Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling Galaxy Wrist Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0378-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Deviation

    Orthofix Srl is recalling specific lots of 4.8 mm drill bits because a geometrical detail does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0357-2020·2019-11-20

    TriMed Hex Driver Recall Due to Epoxy Coating Defect

    TriMed Inc. is recalling 467 Hex Drivers because the epoxy coating may pop off. The recall covers units distributed nationwide and to several foreign countries.

    Product
    TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0367-2020·2019-11-20

    Randox NEFA FA115 Recalled for Performance Failure

    Randox Laboratories is recalling NEFA FA115 Lot 485343 because it is not meeting performance claims and should not be used for testing.

    Product
    RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0392-2020·2019-11-20

    Orthofix Recalls Prefix II Diaphyseal Complete Kit Due to Drill Bit Design

    Orthofix Srl is recalling the Prefix II Diaphyseal Complete Kit because drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
    Category
    Medical Device
    Distribution
    29 states
  • 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-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
  • SevereFDA (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
  • SevereFDA (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
  • 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-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
  • 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-0213-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Detector Fall Hazard

    Philips is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded 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-0178-2020·2019-11-13

    Medtronic Recalls MiniMed Remote Transmitters for Security Vulnerability

    Medtronic is recalling MiniMed Model 503 Remote Transmitters due to a potential security vulnerability affecting insulin pump accessories.

    Product
    Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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