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

1051–1075 of 5027

SevereFDA (Devices)·Z-1301-2024·2024-03-27
HeartMate 3 Left Ventricular Assist System recalled for outflow graft obstruction
The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.
Product
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LV
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1275-2024·2024-03-27
Smiths Medical Pneupac Plus 300 Ventilator Cycling Malfunction
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.
Product
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1300-2024·2024-03-27
FDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction
Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.
Product
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular As
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1267-2024·2024-03-27
ARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
ARROW International is recalling 1,160,470 QuickFlash radial artery catheterization devices due to a defective guidewire handle that can cause arterial vasospasm and vessel injury.
Product
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) R
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1284-2024·2024-03-20
Vascular guide catheter recalled due to distal end fracture risk
Medos is recalling CERENOVUS CEREBASE DA Guide Sheaths due to reports of fractures at the distal end. Fractures may delay surgical procedures or cause vascular injury.
Product
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1186-2024·2024-03-13
MIC Gastric-Jejunal Feeding Tube Kits Recalled Over Defective Syringe
Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits because they contain a sterile pre-filled syringe that was subsequently recalled by Nurse Assist. Approximately 10,808 units have been distributed worldwide.
Product
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Pla
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1187-2024·2024-03-13
Avanos Medical recalls MIC gastric-jejunal feeding tubes with defective syringe
Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits containing a sterile pre-filled syringe that was recalled by Nurse Assist. Approximately 53,126 units were distributed worldwide.
Product
MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Co
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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
SevereFDA (Devices)·Z-1094-2024·2024-03-06
Medline Arterial Irrigation Bundles Recalled Due to Sterility Risk
Medline Industries recalls arterial irrigation bundles due to potential loss of sterility in Nurse Assist components, which could deliver non-sterile solutions for medical procedures.
Product
MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
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-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-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
SevereFDA (Devices)·Z-1135-2024·2024-03-06
Medline recalls Centurion Laceration Trays for potential sterility defect
Medline Industries recalls 576 units of Centurion Laceration Trays nationwide because Nurse Assist-supplied components may lack sterility, posing potential health risks in medical procedures.
Product
Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
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-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-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-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-1105-2024·2024-03-06
Medline Dialysis Kits Recalled for Potential Sterility Defects
Medline Industries is recalling certain dialysis kits and trays due to potential sterility defects in component irrigation solutions and saline products. Non-sterile solutions used in dialysis could cause infection.
Product
MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
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

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1051–1075 of 5027