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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7651–7675 of 27441

  • 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-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-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-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-2061-2023·2023-07-12

    BETTA LINK LG Implant Drill Guide Bending Risk

    T.A.G. MEDICAL PRODUCTS is recalling BETTA LINK LG KNOTLESS IMPLANT KIT because drill guides may bend during surgical use, potentially creating metal shavings that could injure patients.

    Product
    BETTA LINK LG 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: 110045160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2023·2023-07-12

    SurgiMend 3.0 Soft Tissue Graft Recalled for Endotoxin Testing Defect

    SurgiMend 3.0 collagen matrix is being recalled nationwide (13,390 units) due to possible endotoxin contamination from deficiencies in endotoxin testing procedures.

    Product
    SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2023·2023-07-12

    Treadmill Recalled for Drive PCB Malfunction Causing Unexpected Belt Movement

    Full Vision Inc is recalling approximately 565 TrackMaster TMX428 treadmills due to a drive circuit board malfunction that can cause the belt to unexpectedly stop, reverse, or accelerate, posing a risk of falls or injury.

    Product
    TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2023·2023-07-12

    BD Synapsys Informatics Solution risks patient data mis-association

    The BD Synapsys Informatics Solution may incorrectly associate patient demographic data under specific conditions when the system operates near capacity during rapid manual result processing.

    Product
    BD Synapsys Informatics Solution, Catalog Number 444150
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2081-2023·2023-07-12

    PriMatrix Ag Fenestrated dermal repair scaffolds recalled for endotoxin testing issues

    TEI Biosciences recalled 7,264 units of PriMatrix Ag Fenestrated dermal repair scaffolds nationwide due to possible out-of-specification endotoxin test results caused by testing methodology defects.

    Product
    PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2023·2023-07-12

    Custom Medical Procedure Packs Recalled for Compromised Package Seals

    DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.

    Product
    Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
    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
  • 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-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-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-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-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-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-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-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-2086-2023·2023-07-12

    Medical procedure packs recalled for compromised package seals

    DeRoyal Industries is recalling 4,225 custom medical procedure packs nationwide because outer package seals may be open or compromised, potentially affecting sterility of the surgical materials inside.

    Product
    Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89
    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-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-2070-2023·2023-07-12

    Surgical collagen matrix recall due to endotoxin testing failures

    TEI Biosciences is recalling 22,163 units of SurgiMend PRS collagen matrices due to endotoxin testing deficiencies that may have resulted in contaminated products being distributed. No injuries have been reported.

    Product
    SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm
    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-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