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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

7551–7575 of 27393

HighFDA (Devices)·Z-2075-2023·2023-07-12
SurgiMend 4.0 Collagen Implants Recalled for Endotoxin Testing Failures
TEI Biosciences is recalling 5,664 units of SurgiMend 4.0 soft tissue reconstruction implants nationwide due to issues with endotoxin testing that may have resulted in out-of-specification test results.
Product
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
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-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-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-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-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-2068-2023·2023-07-12
OmniTom CT imaging device recalled for wheel loosening and battery contamination
NeuroLogica is recalling OmniTom CT imaging devices due to wheels that may loosen and battery boards that may be contaminated, both of which could prevent the device from operating properly and delay patient imaging.
Product
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
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-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-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-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-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
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-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-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-2053-2023·2023-07-12
TrackMaster TMX428 Treadmill drive circuit board malfunction recall
Drive board malfunction in TrackMaster TMX428 treadmills can cause unexpected belt reversal or acceleration, creating fall and impact injury risks. 376 units affected.
Product
TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927
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-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-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-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-2066-2023·2023-07-12
LinkSymphoKnee Distal Femoral Augment Recalled for Improper Screw Placement
The LinkSymphoKnee Distal Femoral Augment is being recalled because fixation screws were inserted in the wrong direction during manufacturing. The improper placement could affect the implant's structural stability.
Product
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
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-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

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7551–7575 of 27393