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

9676–9700 of 40095

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

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