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 deaths or serious injuries are reported, 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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9651–9675 of 13717

  • HighFDA (Devices)·Z-1349-2023·2023-04-12

    Abbott Alinity m System Recall: Missing Components and Improper Calibration

    Abbott Molecular recalled one Alinity m System diagnostic unit installed without required plunger assemblies and returned to service without proper calibration. This could result in delayed or incorrect test results.

    Product
    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1346-2023·2023-04-12

    Terumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding

    Terumo Cardiovascular is recalling CAPIOX NX19 oxygenators with improperly bonded arterial thermistors that may leak. Eighty-four units were distributed across the US and internationally.

    Product
    CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2023·2023-04-12

    Medtronic Grafton Plus Paste surgical implant recall due to packaging defects

    Medtronic is recalling 37,721 units of Grafton Plus Paste surgical implant material due to potential packaging defects in the sterile pouch system that could compromise sterile barrier integrity.

    Product
    Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T4500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2023·2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss

    Stryker's non-sterile disposable tourniquet cuff may fail to achieve or maintain proper pressure during surgical setup, potentially causing blood loss or hemorrhage. Approximately 1,979 units distributed nationwide are affected.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2023·2023-04-12

    Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances

    Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.

    Product
    Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2023·2023-04-12

    Stryker Disposable Tourniquet Cuff Recalled for Pressure Regulation Failure

    Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2023·2023-04-12

    CAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding

    Terumo Cardiovascular Systems is recalling 4,940 CAPIOX FX25 oxygenators because an arterial thermistor component may be improperly bonded to the oxygenator port, potentially causing leaks.

    Product
    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2023·2023-04-12

    Medtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance

    Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.

    Product
    Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2023·2023-04-12

    Tempus Pro Patient Monitor power supplies recalled for fluid ingress and safety issues

    Remote Diagnostic Technologies is recalling 5,540 Tempus Pro Patient Monitors due to fluid ingress and basic safety issues identified with power supplies during internal testing.

    Product
    Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2023·2023-04-12

    CAPIOX RX15 Oxygenator units recalled due to improper thermistor bonding

    Terumo is recalling CAPIOX RX15 Hollow Fiber Oxygenators due to improper bonding of the arterial thermistor, which may cause leaks at the connection port.

    Product
    CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2023·2023-04-12

    Medtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall

    Medtronic is recalling Grafton DBF bone matrix products due to potential packaging defects in the dual-barrier sterile pouch system. The defects could lead to a breach in the sterile barrier.

    Product
    Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2023·2023-04-12

    Endoscopic vessel harvesting system recalled for sterilization defect

    900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.

    Product
    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2023·2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2023·2023-04-12

    Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall

    Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.

    Product
    Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Deminera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2023·2023-04-12

    CooperSurgical embryo culture medium product substitution recall

    CooperSurgical is recalling Global Total LP embryo culture medium after discovering affected units may contain a different medium lacking the required protein source for embryo development.

    Product
    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2023·2023-04-12

    Medtronic Grafton Flex bone graft products recalled for packaging integrity defects

    Medtronic is recalling Grafton Flex demineralized bone matrix products due to potential packaging non-conformances that could compromise sterile barrier integrity. Approximately 2,987 units were distributed worldwide.

    Product
    Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2023·2023-04-12

    Medtronic Grafton Matrix Bone Graft Packaging Sterility Concerns

    Medtronic is recalling Grafton Matrix bone graft products due to potential packaging defects that could compromise sterility. A total of 19,057 units were distributed worldwide.

    Product
    Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2023·2023-04-12

    Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects

    Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.

    Product
    Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2023·2023-04-12

    Biosense Webster guiding sheath recalled for labeling mismatch

    Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.

    Product
    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1319-2023·2023-04-12

    Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.

    Product
    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2023·2023-04-05

    Covidien Shiley Lo-Pro Tracheal Tube Cuffed Recalled for Potential Inflation System Leaks

    Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.

    Product
    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1292-2023·2023-04-05

    Surgical navigation system recalled for potential mechanical instability

    Brainlab AG is recalling Cirq Arm System 2.0 devices due to potential mechanical instability from manufacturing errors. Users should discontinue use and contact the manufacturer.

    Product
    Cirq Arm System 2.0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1285-2023·2023-04-05

    Dental Implant Titanium Base Recalled for Stability and Fracture Risk

    Preat Corp is recalling Neodent GM X 6mm titanium base components due to a dimensional defect causing vertical movement. This instability may lead to abutment fracture and potential ingestion of dental materials by patients.

    Product
    Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2023·2023-04-05

    Disposable Tourniquet Cuffs Recalled Due to Pressure Failure

    Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.

    Product
    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135;
    Category
    Medical Device
    Distribution
    50 states