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

7851–7875 of 40007

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-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-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
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-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-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-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-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-1194-2024·2024-03-06
Integra Cranial Access Kit Recalled for Sterile Packaging Defect
Integra LifeSciences is recalling 27 units of its Cranial Access Kit due to defective sterile packaging that may compromise product sterility. The kits were distributed worldwide.
Product
Ref No: HITHSP04 / 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-1209-2024·2024-03-06
Colonoscope Recall: Missing Protective Adhesive May Cause Device Failure
Olympus Corporation is recalling 18 colonoscopes with missing adhesive that protects against physical stress. The missing protective adhesive could allow device failure under vibration, temperature fluctuation, or shock.
Product
Colonoscope, Model Number PCF-H180AL.
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-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-1184-2024·2024-03-06
Rebstock Holding Rod for Fixation May Move Uncontrollably
The Rebstock Holding rod for fixation, a surgical instrument, may move or twist uncontrollably during use, potentially compromising patient safety if the movement transfers to attached equipment.
Product
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1199-2024·2024-03-06
Integra Cranial Access Kit recall over sterile packaging defect
Integra LifeSciences is recalling the Cranial Access Kit due to a defect in the sterile packaging that may compromise product sterility. Affects 30 units distributed worldwide.
Product
Ref No: INS7270 / 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-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-1193-2024·2024-03-06
Cranial Access Kit recalled due to sterile packaging integrity defect
Integra LifeSciences is recalling a Cranial Access Kit due to packaging defects that may compromise sterility. The product was distributed worldwide.
Product
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
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-1216-2024·2024-03-06
USTAR II Knee System implants recalled for potential stem misalignment
The FDA is recalling USTAR II Knee System implants due to potential incorrect orientation of the curved stem. The defect may affect proper implant positioning in knee replacement surgery.
Product
USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x1
Category
Medical Device
Distribution
9 states
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-1201-2024·2024-03-06
Integra Cranial Access Kit Recalled for Compromised Sterile Packaging
Integra LifeSciences is recalling 8,906 units of the Cranial Access Kit because the sterile packaging failed integrity testing, potentially compromising sterility. Units were distributed worldwide.
Product
Ref No: INSHITH / 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-1208-2024·2024-03-06
Colonoscope Model CF-Q180AL Recalled Due to Missing Protective Adhesive
Olympus is recalling two colonoscopes (Model CF-Q180AL, serial numbers 2602060 and 2603763) due to missing protective adhesive that normally guards against vibration, temperature changes, and shock loads.
Product
Colonoscope, Model Number CF-Q180AL.
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-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
HighFDA (Devices)·Z-1196-2024·2024-03-06
Integra cranial access kit recalled for sterile packaging failure
Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.
Product
Ref No: INS5HND / 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-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

How to read this listing

Filters

7851–7875 of 40007