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 13717

  • 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
  • HighFDA (Devices)·Z-2065-2023·2023-07-12

    Betta Link LG Surgical Guide May Deform and Produce Metal Shavings

    Betta Link LG surgical guides used in soft tissue and bone repair may bend under pressure during surgery, potentially releasing metal shavings that could injure patients. The manufacturer is recalling affected units in the U.S. and internationally.

    Product
    Betta Link LG Reusable Fishmouth 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: 110045157
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2023·2023-07-12

    Treadmill recalled for drive PCB malfunction causing unexpected acceleration

    Full Vision Inc recalls 95 TRACKMASTER GE T2100-ST2 treadmills with a defective drive PCB that may misread signals, causing the equipment to unexpectedly stop, reverse, or accelerate forward.

    Product
    TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2023·2023-07-12

    Giraffe OmniBed neonatal incubator recall due to incorrect secondary latch installation

    GE HealthCare is recalling Giraffe OmniBed neonatal incubators with potentially incorrect secondary latches on bedside panels. An incorrect latch type may have been installed on northeast and/or northwest panels of affected units.

    Product
    Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2085-2023·2023-07-12

    Soft tissue repair matrix recalled due to possible endotoxin contamination

    TEI Biosciences is recalling 4,832 units of TissueMend Advanced Soft Tissue Repair Matrix due to possible out-of-specification endotoxin test results. No illnesses or injuries have been reported.

    Product
    TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
    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-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-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-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-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-2069-2023·2023-07-12

    SurgiMend soft tissue collagen matrix recalled for endotoxin testing verification issues

    TEI Biosciences recalls 14,535 units of SurgiMend collagen matrices distributed nationwide due to potential endotoxin testing verification problems. Affected devices cannot be confirmed to meet endotoxin specifications.

    Product
    SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4
    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-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-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-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-2080-2023·2023-07-12

    PriMatrix Ag Dermal Repair Scaffold Recalled for Endotoxin Testing Issues

    TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.

    Product
    PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2023·2023-07-12

    BETTA LINK SR Reusable Fishmouth Guide may bend and shed metal shavings

    T.A.G. Medical Products is recalling BETTA LINK SR Reusable Fishmouth Guides (Part Number 110045151) because the drill guides may bend during surgical use and result in metal shavings. The risk to patients includes potential injury.

    Product
    BETTA LINK SR REUSABLE FISHMOUTH 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: 110045151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2023·2023-07-12

    Dermal Repair Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling PriMatrix Meshed dermal repair scaffolds due to endotoxin testing failures. The recall affects 33,277 units distributed nationwide.

    Product
    PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2023·2023-07-12

    Fenestrated Graspers Recalled Due to Potential Breakage and Fragment Risk

    Intuitive Surgical is recalling 46,033 da Vinci Xi/X Tip-Up Fenestrated Graspers worldwide due to a manufacturing issue that can cause grip breakage, potentially allowing stainless steel fragments to enter the patient.

    Product
    da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2023·2023-07-12

    PriMatrix Dermal Repair Scaffold recalled due to endotoxin testing issues

    TEI Biosciences is recalling 4,159 units of PriMatrix Dermal Repair Scaffold nationwide due to possible out-of-specification endotoxin test results. Quality control issues during testing led to this recall.

    Product
    PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-2078-2023·2023-07-12

    PriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues

    TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.

    Product
    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
    Category
    Medical Device
    Distribution
    Distributed nationwide