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

7101–7125 of 13652

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-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
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-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-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-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-1090-2024·2024-03-06
Medline Tracheal Care Trays Recalled Due to Sterility Concerns
Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.
Product
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
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-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-1163-2024·2024-03-06
Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, 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-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-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
HighFDA (Devices)·Z-1203-2024·2024-03-06
Integra Cranial Access Kit Recalled Due to Sterile Packaging Defect
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in sterile packaging that could compromise product sterility. The device is used for neurosurgical access to the brain.
Product
Ref No: INSHITHRZN / 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-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-1182-2024·2024-03-06
IdentiTi ALIF surgical graft bolts recalled due to intraoperative breakage
Alphatec Spine recalls IdentiTi ALIF graft bolts after reports of breakage during implantation. Approximately 12,777 devices are affected worldwide.
Product
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1183-2024·2024-03-06
Infusion Pumps Model Z-800WF Recalled Due to Alarm Volume Malfunction
Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.
Product
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1214-2024·2024-03-06
Colonoscope Model PCF-Q180AL Recalled Due to Missing Protective Adhesive
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
Product
Colonoscope, Model Number PCF-Q180AL.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1212-2024·2024-03-06
Olympus colonoscope PCF-H190TL recalled for missing protective adhesive
Olympus has recalled certain repaired colonoscope models lacking protective adhesive that could fail under vibration, temperature, or severe shock loads. Affected models include the PCF-H190TL, distributed nationwide.
Product
Colonoscope, Model Number PCF-H190TL.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1206-2024·2024-03-06
Colonoscope Model CF-HQ190I recalled for missing protective adhesive
Olympus is recalling certain repaired Model CF-HQ190I colonoscopes assembled without protective adhesive, which may cause equipment failure under vibration, temperature changes, or shock.
Product
Colonoscope, Model Number CF-HQ190I.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1211-2024·2024-03-06
Colonoscope Model PCF-H190L Recalled for Missing Protective Adhesive
Olympus Corporation recalled 31 colonoscopes lacking a protective adhesive that shields against vibration, temperature fluctuations, and shock. The missing adhesive may affect device structural integrity under physical stress.
Product
Colonoscope, Model Number PCF-H190L.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1191-2024·2024-03-06
Dialysis Accessory Device Recalled for Blood Leakage Risk
The NxStage Cartridge Express dialysis device is recalled because blood can leak or spray from the arterial line. This could cause uncontrolled blood loss in patients or expose healthcare workers to infectious blood.
Product
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
Category
Medical Device
Distribution
19 states
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
HighFDA (Devices)·Z-1219-2024·2024-03-06
Hip Implant Component Mislabeled With Wrong Insert Type on Packaging
LINK BiMobile hip implant liners are being recalled because packaging incorrectly identifies the insert type as F instead of G. This labeling error could delay surgery or result in the wrong component being used.
Product
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2024·2024-03-06
Integra Cranial Access Kit recalls due to packaging sterility defect
Integra LifeSciences is recalling 161 units of the Cranial Access Kit (Lot 7124720) due to packaging defects that may compromise sterility. The recall affects units distributed worldwide.
Product
Ref No: INS7260 / 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-1205-2024·2024-03-06
Colonoscope Model CF-H180AL Recalled Due to Missing Protective Adhesive
Olympus is recalling 36 colonoscopes with specific serial numbers that lack a protective adhesive, risking device failure if exposed to vibration, temperature changes, or shock loads.
Product
Colonoscope, Model Number CF-H180AL.
Category
Medical Device
Distribution
Distributed nationwide

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7101–7125 of 13652