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

6901–6925 of 13512

HighFDA (Devices)·Z-1234-2024·2024-03-13
Titanium Hindfoot Arthrodesis Cannulated Nails Recalled Due to Sterilization Failure
Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.
Product
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1239-2024·2024-03-13
TFNA Femoral Nail surgical implant recalled for sterility failure
Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.
Product
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1253-2024·2024-03-13
Apollo Onyx Delivery Microcatheter recalled for incorrect indications for use
Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.
Product
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1221-2024·2024-03-13
VITROS diagnostic systems may produce erroneous results from sample container aspiration
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
Product
VITROS 5600 Integrated System (New and Refurbished)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1263-2024·2024-03-13
Orthopedic knee implant recalled for potential sterile packaging breaches
Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential breaches in the sterile packaging. The breaches could compromise product sterility and safety.
Product
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2024·2024-03-13
VITROS 4600 Chemistry System Software Defect Affects Quality Control Reporting
A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.
Product
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1227-2024·2024-03-13
Medical Device Recall: VITROS XT 3400 Chemistry System Software Defect
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.
Product
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2024·2024-03-13
ConvaTec Natura Stomahesive surgical ostomy system pouch-flange coupling mismatch
ConvaTec Natura Stomahesive ostomy kits contain a 45mm flange but 57mm pouch, creating an incompatible coupling. The mismatch prevents the components from fitting together properly.
Product
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1248-2024·2024-03-13
MRI Systems Show Incorrect Spatial Field Gradient Values
Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.
Product
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1258-2024·2024-03-13
Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions
Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.
Product
Embrace Drill Tower, Standard/Lateral (25mm)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1091-2024·2024-03-06
Medline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions
Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.
Product
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1113-2024·2024-03-06
Medline Medical Kits Recalled Due to Potential Lack of Sterility
Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.
Product
Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445;
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1070-2024·2024-03-06
VOCSN Pediatric breathing package spiral wrap detachment risk during ventilation
Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.
Product
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ven
Category
Medical Device
Distribution
8 states
CriticalFDA (Devices)·Z-1136-2024·2024-03-06
Centurion LVAD Maintenance Kits Recalled for Potential Sterility Failure
Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.
Product
Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1102-2024·2024-03-06
Surgical kits and trays recalled due to lack of sterility
Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRI
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1120-2024·2024-03-06
Medline wound care trays recalled due to sterility defect
Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1123-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Sterility Failure
Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1138-2024·2024-03-06
Medline circumcision surgical kits recalled for sterility concerns
Medline Industries is recalling circumcision surgical trays due to potential lack of sterility in component solutions. The recall affects 1260 units distributed across the US, Puerto Rico, Canada, UAE, and Panama.
Product
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1125-2024·2024-03-06
Medline Irrigation Kits and Packs Recalled for Sterility Defect
Medline Industries recalls 279 irrigation and saline kits, trays, and packs due to potential lack of sterility in components used to manufacture them. Solutions may be non-sterile.
Product
Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1122-2024·2024-03-06
Medline kits and trays recalled for potential lack of sterility
Medline Industries is recalling surgical kits and trays containing irrigation solutions that may not be sterile due to manufacturing issues. The non-sterile solutions could increase infection risk during surgical and obstetrical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1130-2024·2024-03-06
Medline Centurion dialysis kits recalled due to sterility concerns
Medline Industries is recalling approximately 10,391 Centurion dialysis kits due to potential lack of sterility in Nurse Assist components. Products were distributed nationwide and in select international locations.
Product
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1097-2024·2024-03-06
Medline Medical Kits and Trays Recalled for Non-Sterile Solutions
Medline Industries is recalling multiple medical kits and trays containing irrigation solutions that may be non-sterile. The affected products are used in surgical and invasive procedures; non-sterile solutions could cause serious infections.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1119-2024·2024-03-06
Medline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns
Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1107-2024·2024-03-06
Dialysis Irrigation Solutions Recalled for Potential Sterility Defect
Medline Industries is recalling 10,391 units of dialysis kits and accessory packs due to potential sterility defects in component solutions. Non-sterile irrigation fluids could cause serious infection if used.
Product
Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1061-2024·2024-03-06
AirLife Adult Manual Resuscitator Recalled for Ventilation Failure Risk
Vyaire Medical recalls 3.6 million AirLife Adult Manual Resuscitators due to defective oxygen tubing components that may fail to deliver proper ventilation, risking hypoxia. Affected units were manufactured in 2017 or earlier.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
Category
Medical Device
Distribution
Distributed nationwide

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6901–6925 of 13512