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

5976–6000 of 27393

SevereFDA (Devices)·Z-1165-2024·2024-03-06
Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk
Medtronic is recalling 11,840 units of its Duet External Drainage and Monitoring System due to potential disconnection between the catheter and stopcock connectors. This defect could impair the device's ability to drain cerebrospinal fluid.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
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-1164-2024·2024-03-06
Medtronic Duet External Drainage System catheter disconnection risk recalled
Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
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-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-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-1110-2024·2024-03-06
Medline wound irrigation kits recalled for potential sterility defects
Medline Industries is recalling approximately 2,205 wound irrigation kits due to potential lack of sterility in component solutions. Non-sterile irrigation solutions pose a risk of infection during wound care.
Product
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1101-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Sterility Defects
Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ4
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-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-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-1104-2024·2024-03-06
Medline Catheterization Kits Recalled for Potential Sterility Defect
Medline Industries is recalling catheterization kits for potential sterility defects in component irrigation solutions. Non-sterile solutions used in medical procedures could result in serious infections.
Product
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1060-2024·2024-03-06
AirLife Adult Manual Resuscitator Kits Recalled for Component Failure
Vyaire Medical is recalling 3,636 AirLife Adult Manual Resuscitator kits. Manufacturing defects can cause component failure that prevents proper ventilation, potentially resulting in fatal hypoxia.
Product
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
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-1103-2024·2024-03-06
Medline surgical kits and trays recalled for sterility defects
Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222;
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-1099-2024·2024-03-06
Medline Centurion maintenance flush kits recalled for sterility failure
Medline Industries is recalling Centurion maintenance flush and blood draw kits that may lack sterility due to defective components, potentially allowing infections during medical procedures.
Product
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1126-2024·2024-03-06
Medline Surgical Kits Recalled for Potential Sterility Failure
Medline Industries recalls surgical kits and trays manufactured with non-sterile solutions due to contaminated Nurse Assist components. Kits distributed nationwide and internationally may lack proper sterility, posing infection risk.
Product
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2024·2024-03-06
Colonoscope Model PCF-HQ190L Recalled for Missing Protective Adhesive
Olympus is recalling 28 colonoscopes (Model PCF-HQ190L) due to missing adhesive that protects the device from vibration, temperature changes, and physical shock. The defect could cause device malfunction during procedures.
Product
Colonoscope, Model Number PCF-HQ190L.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1197-2024·2024-03-06
Integra Cranial Access Kit Recalled Due to Packaging Integrity Defect
Integra LifeSciences is recalling 188 units of the Integra Cranial Access Kit because defective sterile packaging may have compromised product sterility.
Product
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1207-2024·2024-03-06
Colonoscope Model CF-HQ190L Recalled Due to Missing Protective Adhesive
Olympus Corporation is recalling 97 Colonoscope Model CF-HQ190L units distributed nationwide. The devices were assembled without protective adhesive, risking malfunction under vibration, temperature changes, or shock.
Product
Colonoscope, Model Number CF-HQ190L.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1210-2024·2024-03-06
Olympus Colonoscope Recall: Missing Protective Adhesive in 47 Units
Olympus is recalling 47 colonoscope units (Model PCF-H190DL) because they were assembled without protective adhesive. The missing adhesive may cause equipment failure under vibration, temperature changes, or shock.
Product
Colonoscope, Model Number PCF-H190DL.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1217-2024·2024-03-06
Orthopedic knee implant recall due to potential stem misalignment
United Orthopedic Corporation recalls USTAR II knee implants due to potential incorrect orientation of the curved stem. Affected products were distributed across multiple US states and internationally.
Product
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1202-2024·2024-03-06
Integra Cranial Access Kit Recalled for Defective Sterile Packaging
Integra LifeSciences is recalling 915 units of its Cranial Access Kit worldwide due to defective sterile packaging that may compromise product sterility. The header bags failed required packaging integrity testing.
Product
Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1200-2024·2024-03-06
Integra Cranial Access Kit Recall Due to Sterile Packaging Defect
Integra LifeSciences is recalling the INS7280 Cranial Access Kit due to a packaging defect that may compromise product sterility. The recall affects 82 units distributed worldwide.
Product
INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Category
Medical Device
Distribution
Distributed nationwide

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5976–6000 of 27393