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

7801–7825 of 39968

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-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
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-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-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-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
SevereFDA (Devices)·Z-1124-2024·2024-03-06
Medline Surgical Kits Recalled Due to Sterility Defect in Irrigation Solutions
Medline Industries recalls certain surgical kits and trays because irrigation solution components may lack sterility, creating potential infection risk.
Product
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1133-2024·2024-03-06
Medline Tracheostomy Care Trays Recalled for Sterility Issues
Medline Industries is recalling 528 latex-free tracheostomy care trays due to potential sterility failure in component irrigation solutions. Non-sterile solutions pose infection risk.
Product
Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1128-2024·2024-03-06
Medline Suction Catheter Kits Recalled for Potential Sterility Defects
Medline Industries is recalling 1,012,700 suction catheter kits manufactured with irrigation solutions that may lack sterility. The recalled products are distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1059-2024·2024-03-06
AirLife Adult Manual Resuscitator recalled for faulty component causing ventilation failure
Vyaire Medical is recalling 8,220 AirLife Adult Manual Resuscitators with defective duckbill and ring components. The manufacturing defect may prevent proper ventilation and could lead to hypoxia or death.
Product
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1137-2024·2024-03-06
Centurion breast biopsy kits recalled due to potential sterility issues
Medline Industries is recalling Centurion breast biopsy kits due to a potential lack of sterility in component solutions.
Product
Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1116-2024·2024-03-06
Medline Prep Kits Recalled Due to Non-Sterile Components
Medline is recalling 1,270 prep kits containing components that may lack sterility. Solutions from Nurse Assist used in the kits may not be sterile.
Product
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1063-2024·2024-03-06
AirLife Adult Manual Resuscitator recalled for ventilation failure risk
Vyaire Medical is recalling 4,572 units of AirLife Adult Manual Resuscitators due to defective components that may cause improper ventilation or complete ventilation failure, potentially resulting in hypoventilation, hypoxia, or death.
Product
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1065-2024·2024-03-06
AirLife Manual Resuscitator recalled for broken components causing ventilation failure
Vyaire Medical is recalling approximately 1.8 million AirLife Adult Manual Resuscitators worldwide due to faulty molded components that may fail to deliver proper ventilation, risking hypoventilation and hypoxia.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
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-1127-2024·2024-03-06
Medline Surgical Kits and Trays Recalled Due to Potential Sterility Defect
Medline Industries is recalling surgical kits and trays that may contain non-sterile irrigation solutions. Affected products were manufactured with certain component lots that have a potential sterility defect.
Product
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1132-2024·2024-03-06
Medline Centurion surgical trays and kits recalled for potential non-sterile solutions
Medline Industries is recalling 14,234 units of Centurion surgical kits and trays that may contain non-sterile irrigation solutions. The affected products were manufactured using compromised Nurse Assist components.
Product
Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1095-2024·2024-03-06
Medline Medical Kits and Trays Recalled for Potential Sterility Failure
Medline Industries is recalling certain medical kits and trays that may contain non-sterile solutions. Healthcare facilities should discontinue use of affected batches to prevent patient exposure to potential contamination.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1109-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Lack of Sterility
Medline Industries is recalling 139 surgical kits containing irrigation solutions with potential sterility issues. The recalled products were distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1112-2024·2024-03-06
Medline Medical Kits and Trays Recalled for Potential Sterility Failure
Medline Industries is recalling certain sterile medical kits and trays that contain component solutions with a potential lack of sterility. Non-sterile solutions could result in infection or contamination during medical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1114-2024·2024-03-06
Medline Port Removal Kits Recalled for Potential Sterility Loss
Medline Industries recalls certain port removal kits due to potential loss of sterility in irrigation solutions manufactured using specific component lots.
Product
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
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
SevereFDA (Devices)·Z-1062-2024·2024-03-06
AirLife manual resuscitator component defect risks ventilation failure
Vyaire Medical is recalling AirLife Adult Manual Resuscitators with defective duckbill and ring components that may fail to provide ventilation, risking hypoventilation or hypoxia. The defect affects units manufactured in 2017 and earlier.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1093-2024·2024-03-06
Medline Bronchoscopy Tray Components Recalled for Potential Lack of Sterility
Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.
Product
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1058-2024·2024-03-06
AirLife Adult Manual Resuscitator tubing may fail to deliver proper ventilation
Vyaire Medical is recalling 66,078 units of AirLife Adult Manual Resuscitator oxygen tubing worldwide due to component manufacturing defects that can cause device failure and inadequate ventilation.
Product
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
Category
Medical Device
Distribution
Distributed nationwide

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7801–7825 of 39968