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

39876–39900 of 40356

HighFDA (Devices)·Z-2291-2012·2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.
Product
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2012·2012-09-05
Mindray Recalls V Series Patient Monitors Due to Software Anomalies
Mindray is recalling 979 V Series Patient Monitors worldwide due to two identified software anomalies. No injuries have been reported.
Product
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2012·2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected lot is 052709-01.
Product
Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2271-2012·2012-09-05
Biomet 3i Recalls Low Profile Abutments Due to Labeling Errors
Biomet 3i is recalling Low Profile Abutments because some packages labeled as Hexed Castable Cylinders may contain Non-Hexed Castable Cylinders.
Product
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2264-2012·2012-09-05
Siemens syngo Imaging XS Software Recall for Miscalculation Defect
Siemens Medical Solutions is recalling 52 syngo Imaging XS systems due to potential miscalculation of grey scale values in specific image processing functions.
Product
syngo Imaging XS. Radiological image processing system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2283-2012·2012-09-05
Siemens Stratus CS Acute Care D-dimer Calibrator Recall
Siemens is recalling specific lots of D-dimer Calibrators that may cause instrument calibration errors.
Product
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2284-2012·2012-09-05
Steris Recalls QKC1692E Quick Connect Devices Due to Labeling Errors
Steris Corporation is recalling 64 QKC1692E Quick Connect devices because seven endoscope models were not validated for use with the device, requiring label corrections.
Product
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2300-2012·2012-09-05
SRI Surgical Recalls Disposable Accessory Packs Due to Labeling Error
SRI Surgical is recalling 802,135 disposable accessory packs distributed nationwide because they did not meet specifications due to a labeling error.
Product
Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2275-2012·2012-09-05
Siemens syngo.plaza Radiological Image Processing System Recalled for Miscalculation
Siemens Medical Solutions is recalling 14 syngo.plaza systems due to a potential miscalculation in images with pixel depth values greater than 12 bits.
Product
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2270-2012·2012-09-05
Sunquest Laboratory Software Recall for Microbiology Data Entry Errors
Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4 and later due to potential errors in specimen data entry.
Product
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2278-2012·2012-09-05
Toshiba MRI Systems Recalled for Sequence Queue Status Display Error
Toshiba American Medical Systems is recalling 54 EXCELART MRI systems because the status display in the sequence queue window may fail to update from 'Current' to 'Done'.
Product
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2282-2012·2012-09-05
Toshiba Whole Body X-ray Scanner Recalled for Incorrect Data Display
Toshiba is recalling 24 whole body X-ray scanners because incorrect couch positions and scan times may be displayed on reconstructed images.
Product
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2302-2012·2012-09-05
Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Expired Labeling
Encore Medical is recalling 7 units of 3DKnee e+ Tibial Inserts because shelf life labeling was incorrect and the components were expired.
Product
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2273-2012·2012-09-05
Alphatec Recalls Trestle Luxe Anterior Cervical Plating System Components
Alphatec Spine is recalling 38 units of the Trestle Luxe Anterior Cervical Plating System because the Slide Alignment Tool does not fit the plate screws.
Product
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2276-2012·2012-09-05
Advanced Sterilization Products Recalls CIDEX OPA Solution Due to Missing Labels
Advanced Sterilization Products is recalling CIDEX OPA Solution bottles manufactured between May 2011 and April 2012 because some are missing labels.
Product
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2269-2012·2012-09-05
Baxter Mini-Infuser Model 300XL Infusion Pump Recalled for Battery Contact Defect
Baxter Healthcare is recalling 19,380 Mini-Infuser Model 300XL infusion pumps because a battery contact defect may prevent the device from operating.
Product
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2285-2012·2012-09-05
Phadia Varelisa Cardiolipin IgM Test Kits Recalled for Elevated Results
Phadia US Inc is recalling Varelisa Cardiolipin IgM test kits because a material change combined with a prior instruction to omit a pre-wash step caused elevated assay results.
Product
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2277-2012·2012-09-05
Bard Access Systems Recalls HemoStar XK Hemodialysis Catheters for Incorrect Expiration Date
Bard Access Systems is recalling 120 units of 16 Fr HemoStar XK Long-Term Hemodialysis Catheters because they were labeled with an incorrect expiration date.
Product
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min…
Category
Medical Device
Distribution
16 states
LowFDA (Devices)·Z-2268-2012·2012-09-05
Baxter Mini-Infuser 150XL Infusion Pump Recalled for Battery Contact Defect
Baxter Healthcare is recalling Mini-Infuser Model 150XL infusion pumps because a battery contact defect may prevent the device from operating.
Product
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician.…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2205-2012·2012-08-29
CareFusion Recalls Alaris Pump Module 8100 Due to Keypad Overlay Separation
CareFusion 303, Inc. is recalling Alaris Pump Module 8100 units because the keypad overlay may separate from the assembly, posing a potential risk.
Product
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2230-2012·2012-08-29
Terumo Serial Interface Module Recalled for Data Loss and Smoke Odor
Terumo is recalling 579 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions involving data loss and smoke odor.
Product
Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2239-2012·2012-08-29
Philips PET/CT Systems Recalled Due to UPS Battery Thermal Runaway
Philips is recalling seven PET/CT systems because a UPS battery cabinet experienced thermal runaway, causing a battery to overheat and burn through the casing.
Product
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2223-2012·2012-08-29
Philips CT Scanner Recall for Dose Limit Software Defect
Philips is recalling eight Brilliance 64 and Ingenuity CT scanners because a software update allows users to disable dose alerts, potentially permitting scans that exceed safety limits.
Product
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and…
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2233-2012·2012-08-29
Terumo Interface Module for CDl System 500 Recalled for Malfunctions
Terumo is recalling Interface Modules for the CDl System 500 due to reported malfunctions involving loss of data transfer and smoke odor.
Product
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2219-2012·2012-08-29
Siemens syngo Dynamics Version 9.5 Recalled for Potential Image Misplacement
Siemens Medical Solutions is recalling syngo Dynamics Version 9.5 because images from one patient may be placed in another patient's study.
Product
syngo Dynamics Version 9.5
Category
Medical Device
Distribution
Distributed nationwide

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39876–39900 of 40356