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

9651–9675 of 13748

HighFDA (Devices)·Z-1341-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss
Stryker's non-sterile disposable tourniquet cuff may fail to achieve or maintain proper pressure during surgical setup, potentially causing blood loss or hemorrhage. Approximately 1,979 units distributed nationwide are affected.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1335-2023·2023-04-12
Endoscopic vessel harvesting system recalled for sterilization defect
900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.
Product
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1323-2023·2023-04-12
Medtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance
Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.
Product
Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1336-2023·2023-04-12
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Recalled for Sterilization Failure
Maquet Cardiovascular is recalling approximately 2,300 units of the VASOVIEW HEMOPRO 2 system because some batches were not sterilized to specification. This sterilization failure creates a risk of contamination and potential infection during surgical procedures.
Product
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2023·2023-04-12
Stryker Disposable Tourniquet Cuff Recalled for Pressure Regulation Failure
Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2023·2023-04-12
Moberg CNS-350 Neuromonitoring System Recalled for Battery Leakage Risk
Moberg is recalling 89 CNS-350 Neuromonitoring System devices due to battery leakage that can corrode the metal enclosure, potentially causing skin injury. Affected units were distributed worldwide.
Product
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2023·2023-04-12
CAPIOX RX15 Oxygenator units recalled due to improper thermistor bonding
Terumo is recalling CAPIOX RX15 Hollow Fiber Oxygenators due to improper bonding of the arterial thermistor, which may cause leaks at the connection port.
Product
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2023·2023-04-12
Stryker Color Cuff Tourniquet Cuff pressure failure recall
Stryker is recalling 1,730 units of Color Cuff Non-Sterile Tourniquet Cuffs due to failures in achieving and maintaining pressure during setup, which could result in operative site blood loss or hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1330-2023·2023-04-12
Medtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall
Medtronic is recalling Grafton DBF bone matrix products due to potential packaging defects in the dual-barrier sterile pouch system. The defects could lead to a breach in the sterile barrier.
Product
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1327-2023·2023-04-12
Medtronic Grafton Matrix Bone Graft Packaging Sterility Concerns
Medtronic is recalling Grafton Matrix bone graft products due to potential packaging defects that could compromise sterility. A total of 19,057 units were distributed worldwide.
Product
Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1349-2023·2023-04-12
Abbott Alinity m System Recall: Missing Components and Improper Calibration
Abbott Molecular recalled one Alinity m System diagnostic unit installed without required plunger assemblies and returned to service without proper calibration. This could result in delayed or incorrect test results.
Product
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1326-2023·2023-04-12
Medtronic Grafton Orthoblend Surgical Bone Graft Packaging Defect Recall
Medtronic recalls Grafton Orthoblend bone graft products due to potential sterile packaging defects that could compromise product sterility. The packaging non-conformances may allow breach of the dual-barrier protection system.
Product
Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2023·2023-04-12
CAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
Terumo Cardiovascular Systems is recalling 4,940 CAPIOX FX25 oxygenators because an arterial thermistor component may be improperly bonded to the oxygenator port, potentially causing leaks.
Product
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2023·2023-04-12
Terumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
Terumo Cardiovascular is recalling CAPIOX NX19 oxygenators with improperly bonded arterial thermistors that may leak. Eighty-four units were distributed across the US and internationally.
Product
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1344-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1348-2023·2023-04-12
CooperSurgical embryo culture medium product substitution recall
CooperSurgical is recalling Global Total LP embryo culture medium after discovering affected units may contain a different medium lacking the required protein source for embryo development.
Product
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2023·2023-04-12
Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects
Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.
Product
Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2023·2023-04-12
Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall
Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.
Product
Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Deminera
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2023·2023-04-12
FDA Recalls VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System for Sterilization Failure
Maquet Cardiovascular is recalling VASOVIEW HEMOPRO endoscopic vessel harvesting systems because some batches were not sterilized to the required specifications.
Product
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2023·2023-04-12
Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances
Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.
Product
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2023·2023-04-12
Medtronic Grafton DBF Inject bone matrix products recalled for packaging defects
Medtronic is recalling Grafton DBF Inject demineralized bone matrix products due to potential packaging non-conformances that may compromise the sterile barrier. Over 10,000 units distributed worldwide are affected.
Product
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1340-2023·2023-04-12
Stryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery
Stryker tourniquet cuffs may fail to maintain proper pressure during initial setup, potentially causing operative blood loss or hemorrhage during surgical procedures.
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2023·2023-04-12
Medtronic Grafton Gel Surgical Implant Sterile Barrier Packaging Recall
Medtronic is recalling Grafton Gel demineralized bone matrix surgical implants due to packaging non-conformances in the sterile pouch that could compromise the sterile barrier of the implant.
Product
Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120IN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2023·2023-04-12
Tempus Pro Patient Monitor power supplies recalled for fluid ingress and safety issues
Remote Diagnostic Technologies is recalling 5,540 Tempus Pro Patient Monitors due to fluid ingress and basic safety issues identified with power supplies during internal testing.
Product
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supp
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1319-2023·2023-04-12
Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Category
Medical Device
Distribution
Distributed nationwide

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9651–9675 of 13748