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

7401–7425 of 13666

HighFDA (Devices)·Z-0943-2024·2024-02-07
Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies
Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.
Product
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0833-2024·2024-02-07
Orthopedic surgical kits recalled for unassessed external component sterilization
American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.
Product
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0905-2024·2024-02-07
Knee replacement inserts recalled due to material oxidation risk
P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.
Product
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0822-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment
American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0948-2024·2024-02-07
Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury
The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 are affected.
Product
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2024·2024-02-07
Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure
Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.
Product
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0935-2024·2024-02-07
Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures
Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.
Product
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2024·2024-02-07
Knee replacement implants recalled for potential material degradation
Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.
Product
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2024·2024-02-07
PS Lipped Tibial Insert Assy Duracon Knee Implant Oxidation Risk
Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
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-0861-2024·2024-02-07
Azurion 7 M20 Imaging System Recalled for Loss of Arm and Table Movement
Philips Azurion 7 M20 FlexArm systems may lose connectivity due to a date/time software issue, preventing arm and table movement. The defect affects 108 systems worldwide, including 14 in the United States.
Product
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0825-2024·2024-02-07
Surgical Procedure Kits Recalled Due to Improper Sterilization
American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.
Product
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0821-2024·2024-02-07
Gastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures
American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
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-0906-2024·2024-02-07
Knee replacement implant insert recalled due to material degradation risk
Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.
Product
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0924-2024·2024-02-07
Knee Replacement Insert May Degrade from Oxidized Raw Material
Howmedica Osteonics is recalling PS LIPPED TIBIAL INSERT ASSY DURACON knee replacement inserts manufactured with UHMWPE raw material over 5 years old. The aged material may develop elevated oxidation that could impact material properties.
Product
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0900-2024·2024-02-07
Scorpio NRG Tibial Bearing Insert Assembly Recall Due to Material Oxidation Risk
Howmedica Osteonics Corp. is recalling Scorpio NRG Tibial Bearing Insert Assemblies manufactured with raw material over 5 years old, which may develop elevated oxidation affecting implant durability.
Product
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0843-2024·2024-02-07
FX SHOULDER Centered Glenosphere with Screw may contain eccentric component
FX SHOULDER is recalling 4 units of a shoulder glenosphere implant component due to potential manufacturing defects that may result in eccentric product orientation rather than the intended centered design.
Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
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-0867-2024·2024-02-07
Aesculap Needle Holders Distributed With Incorrect Product Labels and Packaging
Aesculap Inc. is recalling needle holder models that were distributed with incorrect product labels. The MB215R was labeled as MB362R and vice versa, which may cause procedural delays.
Product
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2024·2024-02-07
Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement
TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.
Product
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures,
Category
Medical Device
Distribution
5 states
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-0860-2024·2024-02-07
Philips Azurion 7 M20 FlexArm system recalled for software connectivity loss
Philips Medical Systems recalls the Azurion 7 M20 FlexArm system due to a software issue causing loss of connectivity between the FlexArm and Maquet Magnus Table. The recall affects 28 systems worldwide.
Product
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2024·2024-02-07
Knee implant component recalled due to potential material oxidation
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.
Product
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
Category
Medical Device
Distribution
Distributed nationwide

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7401–7425 of 13666