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 13731

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

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8926–8950 of 13731