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

8926–8950 of 13717

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
ModerateFDA (Devices)·Z-2098-2023·2023-07-12
KLS Martin Battery Packs Recalled for Switched Expiration Date Labels
Pro-Dex Inc recalls KLS Martin Battery Packs used in surgical screwdrivers due to manufacturing and expiration dates being reversed on sterile pouch labels, causing batteries to appear prematurely expired.
Product
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2093-2023·2023-07-12
COVID-19 Test Strips Recalled for Lot Number Label Discrepancy
NeuMoDx SARS-CoV-2 test strips from lot 123909 have conflicting lot numbers between the package label and barcode label that the instrument reads.
Product
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). RE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2092-2023·2023-07-12
NexGen Tibial Plate Recalled for Incorrect Outer Packaging Label
Zimmer, Inc. is recalling NexGen Precoat Stemmed Tibial Plate Size 5 devices due to incorrect outer packaging labeling. Affected units were distributed internationally in India.
Product
NexGen Precoat Stemmed Tibial Plate Size 5
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2095-2023·2023-07-12
Teleflex Pilling O'Reilly Esophageal Retractor Recalled for Incomplete Cleaning Instructions
TELEFLEX LLC recalled the Pilling O'REILLY ESOPHAGEAL RETRACTOR (REF 381801A) due to incomplete pre-cleaning instructions in the product's Instructions for Use. The recall affects 365 units distributed nationwide and internationally.
Product
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2096-2023·2023-07-12
Teleflex Surgical Retractor Recalled for Incomplete Pre-Cleaning Instructions
Teleflex LLC is recalling 170 units of the Pilling Lowsley Prostatic Retractor due to incomplete pre-cleaning instructions in the user manual. Incomplete instructions may prevent proper sterilization of the surgical instrument.
Product
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2084-2023·2023-07-12
Collagen matrix recalled for endotoxin testing methodology issues
TEI Biosciences recalled 665 units of Revize-X collagen matrix nationwide due to possible out-of-specification endotoxin test results caused by issues with the company's testing procedures. No illnesses have been reported.
Product
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2071-2023·2023-07-12
SurgiMend collagen matrices recalled for endotoxin test result quality issues
TEI Biosciences recalls SurgiMend 1.0 collagen matrices due to problems with endotoxin testing procedures that may have produced inaccurate test results. 52 units were distributed nationwide.
Product
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1994-2023·2023-07-05
MEGADYNE MEGA 2000 Patient Return Electrode Recalled Due to Patient Burns
The FDA is recalling 21,100 units of the MEGADYNE MEGA 2000 Patient Return Electrode due to reports of patient burns during electrosurgical procedures. All units distributed nationwide are affected.
Product
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide

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8926–8950 of 13717