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

10276–10300 of 13717

HighFDA (Devices)·Z-0472-2023·2022-12-21
Linear accelerator software addresses potential wrong-site treatment risk
Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.
Product
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0556-2023·2022-12-21
Surgical Procedure Trays Recalled Over Incomplete Outer Bag Seals
Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.
Product
HENRY SCHEIN, Vas Pack, Item No.888-2520,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0645-2023·2022-12-21
Medical Device Recall: DeRoyal TOTAL KNEE PACK surgical kit
DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.
Product
DeRoyal TOTAL KNEE PACK, REF 89-9300.08
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0486-2023·2022-12-21
STRADIS HEALTHCARE Oral Surgery Trays Recalled for Potential Sterility Breach
Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.
Product
STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0469-2023·2022-12-21
Zimmer NexGen Option Stemmed Tibial Component Voluntary Recall Due to Higher Revision Rates
Zimmer is recalling NexGen Option Stemmed Tibial Components due to clinically significant higher revision rates when used with specific femoral components. Patients should contact their surgeon to discuss their implant.
Product
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2023·2022-12-21
FDA recalls DeRoyal CRANI PACK medical device over defect
The FDA has recalled DeRoyal CRANI PACK devices (Lot 57389117, expiring 9/1/2026) due to a device defect. The recall affects 16 kits distributed across 23 US states.
Product
DeRoyal CRANI PACK, REF 89-10202.05
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0635-2023·2022-12-21
DeRoyal hip surgical pack recalled in voluntary Class II action
DeRoyal Industries is recalling 8 kits of its TOTAL HIP PACK (Lot 57460930) distributed across 23 U.S. states in a voluntary Class II FDA recall.
Product
DeRoyal TOTAL HIP PACK, REF 89-9113.07
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0473-2023·2022-12-21
BBL Chocolate II Agar laboratory culture media recalled for nutrient deficiency
BBL Chocolate II Agar culture media manufactured by Becton Dickinson contains reduced nutrients and may cause false negative results in laboratory bacterial identification testing.
Product
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2023·2022-12-21
Henry Schein Universal Tray Recall for Incomplete Sealing
Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.
Product
HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0616-2023·2022-12-21
DeRoyal Procedure Packs Recalled for Defective Steri Drape Components
DeRoyal procedure packs containing defective 3M Steri Drapes have been recalled and distributed across the United States.
Product
DeRoyal CUSTOM NEURO PACK, REF 89-8392.09
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0562-2023·2022-12-21
DeRoyal Procedure Packs Recalled Due to Included 3M Steri Drapes
DeRoyal Industries recalls EYE PACK procedure kits because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 156 kits distributed across 23 U.S. states.
Product
DeRoyal EYE PACK, REF 89-4051.09
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0700-2023·2022-12-21
DeRoyal medical device anesthesia pack Class II recall across 23 states
DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall notice.
Product
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0497-2023·2022-12-21
Dental Surgical Pack Recalled Due to Incomplete Sterile Seal
Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.
Product
Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2023·2022-12-21
FDA recalls Henry Schein bone marrow kit for defective seal
Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.
Product
HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0518-2023·2022-12-21
Medical Procedure Trays Recalled for Potential Sterility Breach
Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.
Product
HENRY SCHEIN, CATH PACK Item No.570-2789
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2023·2022-12-21
Stradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing
Stradis Medical is recalling approximately 300 Curved Tip Syringes because manufacturing defects may result in incomplete sealing of the sterile kit, potentially compromising product sterility.
Product
STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0712-2023·2022-12-21
DeRoyal Cataract Pack Surgical Kit Class II Recall
DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.
Product
DeRoyal CATARACT PACK, REF 89-9241.03
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0494-2023·2022-12-21
Surgical Implant Trays Recalled for Incomplete Package Seal
Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.
Product
Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0598-2023·2022-12-21
DeRoyal Spinal Fusion Procedure Packs Recalled for 3M Drape Issue
DeRoyal spinal fusion procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Affected kits were distributed to healthcare facilities across 23 U.S. states.
Product
DeRoyal SPINAL FUSION PACK, REF 89-7515.14
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0490-2023·2022-12-21
Surgical Procedure Tray Recall Due to Incomplete Packaging Seal
Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses reported.
Product
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0477-2023·2022-12-21
Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
Product
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2023·2022-12-21
Surgical Trays Recalled Due to Incomplete Bag Sealing
Stradis Healthcare is recalling surgical trays due to incomplete outer bag sealing that may compromise sterility of the surgical kit.
Product
HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0502-2023·2022-12-21
Breast Augmentation Trays Recalled Due to Incomplete Packaging Seal
Stradis Medical recalls Henry Schein breast augmentation trays due to incomplete outer bag sealing during manufacturing, which may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2023·2022-12-21
Surgical Procedure Trays Recalled Due to Potentially Compromised Sterility
Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising sterility.
Product
STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0512-2023·2022-12-21
Medical and Surgical Procedure Trays Recalled for Incomplete Seal
Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
Category
Medical Device
Distribution
Distributed nationwide

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10276–10300 of 13717