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 the agency’s own highest classification or reported deaths or serious injuries, 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

39776–39800 of 40356

ModerateFDA (Devices)·Z-2413-2012·2012-09-26
FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to packaging mislabeling where product sizes do not match package labels.
Product
Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2415-2012·2012-09-26
Kimberly-Clark MIC Safety PEG Kit Recall Due to Guidewire Size Issue
Kimberly-Clark is recalling 277 units of MIC Safety PEG Kits because the placement guidewire is too large to pass through the introducer needle.
Product
Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2409-2012·2012-09-26
Siemens ADVIA Centaur Prolactin Assay Recalled for Analytical Sensitivity Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Prolactin Assay and Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.
Product
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2431-2012·2012-09-26
Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values
Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which may require more frequent sample dilutions.
Product
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2412-2012·2012-09-26
FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.
Product
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2401-2012·2012-09-26
Zoll X Series Defibrillators Recalled for Incorrect Software
ZOLL Medical Corporation is recalling 11 Zoll X Series Defibrillator/Pacemaker/Monitor units because they were shipped with incorrect software.
Product
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2397-2012·2012-09-26
BD FACS 7-color Setup Beads Recalled for Incorrect CD Version
BD Biosciences is recalling 96 kits of BD FACS 7-color Setup Beads because the included CD contained the incorrect version.
Product
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2393-2012·2012-09-26
Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
Product
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2425-2012·2012-09-26
Kimberly-Clark Recalls Non-Commercial Sterile Surgical Gowns
Kimberly-Clark is recalling 32 cases of sterile surgical gowns that were not intended for commercial distribution to end users.
Product
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2410-2012·2012-09-26
Siemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur FSH Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.
Product
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2394-2012·2012-09-26
Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
Product
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2404-2012·2012-09-26
Philips Brilliance CT 16 System Recalled for Software Logout Failure
Philips is recalling 93 Brilliance CT 16 systems because a software defect may cause the system to fail to log out, requiring a forced restart.
Product
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2430-2012·2012-09-26
Impact Instrumentation Recalls Two On-Board Suction Systems Due to Shipment Mix-Up
Impact Instrumentation, Inc. is recalling two Model 324JL On-Board Suction Systems due to a shipment mix-up. The devices were distributed nationwide, including in Florida and Ohio.
Product
Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2372-2012·2012-09-19
Omni Life Science Recalls Apex Knee System Modular Tibia Augments
Omni Life Science is recalling 310 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising the device's sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2341-2012·2012-09-19
Siemens Uroskop Access Fluoroscopic X-Ray System Recalled for Table Fall Hazard
Siemens is recalling five Uroskop Access fluoroscopic x-ray systems because the table motor may disconnect, causing the table to fall.
Product
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2347-2012·2012-09-19
Philips HeartStart MRx Monitor Defibrillators Recalled for Cable Wear
Philips is recalling HeartStart MRx monitor/defibrillators because wear on the therapy cable connection may cause the device to fail to detect defibrillation pads or paddles.
Product
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2335-2012·2012-09-19
Steris SYSTEM 1E Liquid Sterilant System Recalled for Hose Disconnection
Steris Corporation is recalling 6,051 SYSTEM 1E Liquid Sterilant Processing Systems because the hose can disconnect when the unit is left on, causing water leakage and property damage.
Product
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2012·2012-09-19
Custom Medical Specialties Recalls PVP Prep Solution Due to Lack of Microbial Testing
Custom Medical Specialties is recalling PVP Prep Solution kits because the manufacturer did not perform required microbial testing, meaning the product may not meet specifications.
Product
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2366-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2339-2012·2012-09-19
Intuitive Surgical Recalls Tip Covers for Monopolar Curved Scissors
Intuitive Surgical is recalling 11,121 boxes of disposable tip covers for 8mm monopolar curved scissors due to potential sterility compromise.
Product
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2361-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2365-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits Due to Sterility Issues
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2374-2012·2012-09-19
Omni Life Science Apex Knee System Modular Tibia Augment Recall
Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2012·2012-09-19
Bard Foley procedural trays recalled due to incomplete sterile seals
C.R. Bard is recalling 56,694 units of Bard Foley procedural trays because the sterile packaging seals were incomplete.
Product
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2364-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits for Sterility Issues
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide

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39776–39800 of 40356