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

8851–8875 of 13652

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-2072-2023·2023-07-12
SurgiMend 2.0 Collagen Matrix Recalled for Endotoxin Testing Issues
TEI Biosciences is recalling SurgiMend 2.0 collagen matrices nationwide due to possible out-of-specification endotoxin test results from issues with in-process and finished goods testing procedures.
Product
SurgiMend 2.0; 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, 20x25cm, 10x15cm Semi-Oval,
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

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8851–8875 of 13652