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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8901–8925 of 13731

  • SevereFDA (Devices)·Z-2027-2023·2023-07-12

    FDA Recalls TruSignal AllFit Oximeter Sensors Worldwide for Device Malfunction

    GE Healthcare is recalling 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.

    Product
    TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1974-2023·2023-07-12

    Quidel Triage Cardiac Panel Affected by Troponin Signal Reduction Defect

    Quidel Triage Cardiac Panel diagnostic kits are recalled due to a raw material defect causing approximately 30% troponin signal reduction. The defect won't be detected by quality controls, potentially resulting in missed or delayed heart attack diagnosis.

    Product
    Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-2034-2023·2023-07-12

    Medical Oximeter Sensor Recalled Due to Defibrillation Energy and Voltage Hazards

    GE Healthcare is recalling 237 TruSignal Integrated Ear Sensors worldwide due to potential failures in defibrillation energy delivery, unintended voltage contact, and measurement inaccuracy.

    Product
    TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2026-2023·2023-07-12

    TruSignal adult and pediatric ear oximeter sensors recalled for voltage hazards

    GE Healthcare's TruSignal Adult/Pediatric ear oximeter sensors are recalled worldwide due to potential reduction of defibrillation energy, risk of unintended electrical contact, and inaccurate oxygen measurement.

    Product
    TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2033-2023·2023-07-12

    GE TruSignal Ear Sensor Oximeter Recalled for Defibrillation Energy and Voltage Hazards

    GE Healthcare is recalling 708 TruSignal Integrated Ear Sensors (medical-grade pulse oximeters) due to potential defects that could reduce defibrillation energy, cause electrical shock, or produce inaccurate measurements.

    Product
    TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2060-2023·2023-07-12

    BETTA LINK SR Knotless Implant Kit Drill Guides May Bend During Surgery

    The FDA has recalled BETTA LINK SR Knotless Implant Kits because the drill guides may bend during surgical procedures, potentially releasing metal shavings. This affects surgeons and patients undergoing orthopedic ligament and tendon repair procedures worldwide.

    Product
    BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2023·2023-07-12

    Dermal repair scaffold recalled due to endotoxin testing failures

    TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.

    Product
    PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2023·2023-07-12

    BD Pyxis CII Safe Dispensing Cabinets Recalled for Electrical Current Leakage

    BD Pyxis CII Safe automated dispensing cabinets may leak excessive electrical current when connected to multi-socket power strips, risking electric shock and system downtime.

    Product
    BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2023·2023-07-12

    Teleflex Pilling Surgical Retractor Recalled for Incomplete Cleaning Instructions

    Teleflex recalls the Pilling LOWSLEY PROSTATIC TRACTOR STR due to incomplete pre-cleaning instructions in the product manual. The issue affects 32 units distributed nationwide and internationally.

    Product
    Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2023·2023-07-12

    Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect

    Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.

    Product
    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2057-2023·2023-07-12

    TrackMaster GE Treadmill Recall Due to Drive Circuit Board Malfunction

    Full Vision Inc is recalling 1,416 TrackMaster GE T2100-ST2 220V treadmills worldwide due to a drive circuit board defect that can cause the treadmill to stop suddenly, reverse unexpectedly, or accelerate forward, posing a risk of falls or injury.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2023·2023-07-12

    DeRoyal Pelvic Exam Trays Recalled Due to Compromised Package Seals

    DeRoyal Industries is recalling 3 packs of Pelvic Exam Trays because the outer package seals may be open or compromised, potentially affecting the sterility of the medical procedure packs.

    Product
    Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2023·2023-07-12

    LinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation

    Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.

    Product
    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2023·2023-07-12

    Custom Medical Procedure Packs Recalled for Compromised Package Seals

    DeRoyal Industries is recalling 40 units of STURDI STRAINER TRAY STANDARD procedure packs nationwide due to potentially compromised outer package seals that could affect sterility.

    Product
    Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2023·2023-07-12

    Collagen surgical matrix recalled for potential endotoxin testing issues

    TEI Biosciences is recalling 9,215 units of SurgiMend PRS Meshed, a surgical collagen matrix, due to possible out-of-specification endotoxin test results.

    Product
    SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2023·2023-07-12

    TrackMaster Treadmill Control Malfunction Can Cause Unexpected Acceleration

    Full Vision's TrackMaster treadmill can experience drive PCB malfunctions causing unexpected stopping, reversal, and acceleration. The malfunction affects 264 units distributed worldwide.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2023·2023-07-12

    Ventilator Instructions for Use Contain Translation Error in Korean Materials

    Korean-language instructions for Trilogy Evo ventilators contain a mistranslation where 'invasive' was incorrectly rendered as 'noninvasive.' This error could lead to improper device configuration by Korean-speaking users.

    Product
    Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2064-2023·2023-07-12

    Surgical drill guides may bend and produce metal shavings during use

    T.A.G. MEDICAL PRODUCTS CORPORATION is recalling Betta Link LG Reusable ProngED Guides used in orthopedic surgery because the guides may bend when force is applied, creating metal shavings that could injure patients.

    Product
    Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045156
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2023·2023-07-12

    Aptio Storage and Retrieval Module firmware error may cause incorrect test results

    Siemens Aptio Automation Storage and Retrieval Module has a firmware error that may incorrectly associate test results to patient samples, potentially leading to incorrect patient results. Eighty-three units are affected worldwide.

    Product
    Aptio Automation Storage and Retrieval Module (SRM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2023·2023-07-12

    Giraffe OmniBed neonatal devices recalled due to incorrect secondary latch

    GE HealthCare is recalling approximately 4,540 Giraffe OmniBed and Giraffe OmniBed Carestation neonatal warming devices worldwide due to potentially incorrect secondary latches on bedside panels.

    Product
    Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2073-2023·2023-07-12

    SurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues

    TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.

    Product
    SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2023·2023-07-12

    Revize Collagen Matrix Recalled for Potential Endotoxin Testing Issues

    TEI Biosciences recalls 199 units of Revize Collagen Matrix due to possible out-of-specification endotoxin test results from faulty testing procedures. The product is distributed nationwide.

    Product
    Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2023·2023-07-12

    Giraffe OmniBed bedside panel kits recalled for incorrect secondary latch

    GE HealthCare is recalling Beside panel field replacement unit kits for Giraffe OmniBed devices due to potential incorrect secondary latch installation on northeast and northwest panels.

    Product
    Beside panel FRU (Field Replacement Units) Kits
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2088-2023·2023-07-12

    Medical Procedure Packs with Compromised Package Seals Recalled

    DeRoyal Industries is recalling 328 surgical procedure packs because outer package seals could be open or compromised, affecting product sterility. The affected packs are used in operating rooms nationwide.

    Product
    Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2023·2023-07-12

    Surgical drill guide may bend and produce metal shavings during use

    T.A.G. Medical is recalling BETTA LINK SR surgical drill guides due to risk of bending and metal shavings during surgery.

    Product
    BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045150
    Category
    Medical Device
    Distribution
    Distributed nationwide