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

8201–8225 of 40056

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-0828-2024·2024-02-07
Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects
American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
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-0887-2024·2024-02-07
Knee Replacement Implant Recalled Due to Potential Material Degradation
Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2024·2024-02-07
Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates
Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.
Product
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
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-0826-2024·2024-02-07
Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure
American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2024·2024-02-07
Total Knee Replacement Component Recalled Due to Oxidation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.
Product
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2024·2024-02-07
Tank hose assembly recalled for incorrect material and missing perforations
AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.
Product
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0872-2024·2024-02-07
Knee replacement implant recalled for material oxidation risk
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.
Product
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0917-2024·2024-02-07
Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk
Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.
Product
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0816-2024·2024-02-07
Custom Anesthesia Kits Recalled Over Sterilization Validation Failure
American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.
Product
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0831-2024·2024-02-07
Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure
American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0817-2024·2024-02-07
Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment
American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2024·2024-02-07
EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk
Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.
Product
EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0892-2024·2024-02-07
Knee Replacement Component Recalled Due to Potential Material Degradation
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels affecting material properties.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0879-2024·2024-02-07
Knee Replacement Insert Recalled Due to Potential Material Oxidation
Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.
Product
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0835-2024·2024-02-07
Philips Azurion X-ray System Software Issue Causes Restart and Imaging Loss
Philips Azurion interventional x-ray systems may continuously restart due to a software issue, causing loss of imaging functionality and data. If this occurs during a procedure, the procedure may be delayed or aborted.
Product
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0820-2024·2024-02-07
Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure
American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.
Product
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0901-2024·2024-02-07
Knee replacement poly insert recalled due to material oxidation risk
Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.
Product
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0922-2024·2024-02-07
Knee replacement implant recalled for potential material oxidation risk
Howmedica Osteonics is recalling the DUR PCA MTK REV INS RT knee replacement implant manufactured with UHMWPE material over 5 years old. The material can develop elevated oxidation levels that may degrade its properties.
Product
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2024·2024-02-07
Philips Achieva XR MRI Coil Seal Adhesive Failure Risk
Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.
Product
Achieva XR. Model (REF) Numbers 781153, 781253.
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-0904-2024·2024-02-07
Knee Replacement Component Recalled for Potential Material Degradation
Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT knee replacement components (Lot 61311701, 62122001) due to potential oxidation in aged UHMWPE material that could affect material properties.
Product
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Category
Medical Device
Distribution
Distributed nationwide

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8201–8225 of 40056