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

15426–15450 of 31567

HighFDA (Devices)·Z-0829-2024·2024-02-07
Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss
American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0881-2024·2024-02-07
SCORPIO TS Knee Implant Recall Due to Material Oxidation Risk
Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.
Product
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
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-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-0894-2024·2024-02-07
SCORPIO U-Dome Patella Knee Implant Recalled Due to Material Degradation Risk
Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's material properties.
Product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
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 (Food)·F-0815-2024·2024-02-07
ToYou Snacks Banana Foster Bars Recalled for Undeclared Soy Allergen
Font Group of America Corp. is recalling ToYou Snacks Banana Foster bars due to undeclared soy allergen. Approximately 5,670 units were distributed in the United States.
Product
Banana Foster bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0286-2024·2024-02-07
OralProCare Medicated Lip Treatment Recalled for Manufacturing Specification Deviations
Den-Mat Holdings recalls OralProCare medicated lip treatment due to manufacturing quality control deviations that may affect product conformance to labeled specifications. No illnesses reported.
Product
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
Category
Drug
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-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-0885-2024·2024-02-07
Knee Replacement Insert Recalled Due to Potential Material Oxidation
Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact material properties.
Product
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2024·2024-02-07
EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk
Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.
Product
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0830-2024·2024-02-07
Surgical kits for childbirth recalled for sterilization and functionality risks
American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.
Product
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0908-2024·2024-02-07
Knee Replacement Inserts Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.
Product
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0800-2024·2024-02-07
Hot Sauce Recalled for Missing Wheat Allergen Labeling
Benny T's Vesta Dry Hot Sauce is recalled for labeling that fails to disclose wheat and other ingredient common names. The missing allergen information poses a risk to consumers with wheat allergies.
Product
the original BENNY T'S VESTA DRY HOT SAUCE SCORPION NWT WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99491 1 (Trinidad Moruga Sc
Category
Food
Distribution
24 states
HighFDA (Devices)·Z-0883-2024·2024-02-07
Knee replacement implant insert recalled due to material oxidation risk
Howmedica Osteonics is recalling Scorpio-Flex knee implant inserts manufactured with over-5-year-old UHMWPE material, which may develop elevated oxidation levels that could affect material properties.
Product
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0276-2024·2024-02-07
Budesonide Extended-Release Tablets recalled for failed dissolution specifications
Golden State Medical Supply Inc. is recalling 108 bottles of Budesonide Extended-Release Tablets (9 mg) distributed in Illinois due to failed dissolution specifications.
Product
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Category
Drug
Distribution
0 states
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-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-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-0827-2024·2024-02-07
Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures
American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
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-0890-2024·2024-02-07
Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling a knee replacement patellar component that may have been manufactured with oxidized raw material. Products using UHMWPE over 5 years old can develop elevated oxidation and degraded material properties.
Product
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
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-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

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15426–15450 of 31567