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

8026–8050 of 39844

SevereFDA (Devices)·Z-0941-2024·2024-02-07
Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures
Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.
Product
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0940-2024·2024-02-07
Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures
Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.
Product
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0864-2024·2024-02-07
Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall
The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.
Product
smiths medical Medfusion Model 4000 syringe pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0944-2024·2024-02-07
Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues
Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.
Product
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Oxidation
Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0876-2024·2024-02-07
Knee Implant Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2024·2024-02-07
Medline Blood Culture Collection Kit Recalled for Expired Bactec Component
Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.
Product
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0834-2024·2024-02-07
Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line
An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.
Product
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0874-2024·2024-02-07
Knee replacement tibial insert recalled for potential material oxidation
Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old may have elevated oxidation levels, potentially affecting material properties.
Product
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0952-2024·2024-02-07
Philips MRI Scanner Quadrature Coil Seal Adhesive May Fail and Create Sharp Edges
Philips Intera 1.5T Achieva Nova MRI machines (Model 781172) may develop seal adhesive failure in the Quadrature Body Coil, creating sharp edges that could injure patients during scanning.
Product
Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0873-2024·2024-02-07
Series II Tibial Bear Insert Recalled for Potential Material Degradation
Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.
Product
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2024·2024-02-07
Knee Replacement Implants Recalled for Potential Material Oxidation
Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.
Product
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2024·2024-02-07
Knee Replacement Component Recalled Due to Raw Material Oxidation Risk
Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2024·2024-02-07
Knee Replacement Device Recalled Due to Potential Material Oxidation
Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.
Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2024·2024-02-07
Medline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert
Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.
Product
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2024·2024-02-07
Knee Replacement Implant Components Recalled for Material Degradation Risk
Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.
Product
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0877-2024·2024-02-07
Knee Replacement Implant Insert Recalled Due to Material Degradation Risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement components due to potential oxidation of raw material. Material degradation could affect implant durability.
Product
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0871-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material may develop elevated oxidation levels that could affect the implant's performance.
Product
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0844-2024·2024-02-07
Surgilon Braided Nylon Sutures Recalled for Excessive Gamma Sterilization
Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.
Product
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2024·2024-02-07
EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures
Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.
Product
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0882-2024·2024-02-07
SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2024·2024-02-07
Knee Replacement Component Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling Scorpio NRG Tibial Brg Insert Assembly knee replacement components due to potential oxidation of raw materials over 5 years of age, which could affect material properties.
Product
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Degradation
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0914-2024·2024-02-07
Knee Replacement Inserts Recalled Due to Potential Material Degradation
Howmedica Osteonics is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts manufactured with aging UHMWPE material that has potential for oxidation affecting material properties. Affected lots: 36273601 and 36609701.
Product
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0912-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk
Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.
Product
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Category
Medical Device
Distribution
Distributed nationwide

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8026–8050 of 39844