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

32901–32925 of 40325

LowFDA (Devices)·Z-1754-2015·2015-06-17
Biomet Recalls Hip Components Due to Incorrect GTIN Labeling Codes
Biomet is recalling specific hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1755-2015·2015-06-17
Biomet Shoulder Joint Replacement Components Recalled for Incorrect GTIN Codes
Biomet, Inc. is recalling specific shoulder joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1740-2015·2015-06-17
Acclarent Recalls Expired RELIEVA FLEX Sinus Guide Catheter Units
Acclarent, Inc. is recalling 986 RELIEVA FLEX Sinus Guide Catheter units distributed in Texas because one unit was found to be past its expiry date.
Product
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1756-2015·2015-06-17
Biomet Knee Joint Replacement Components Recalled for Incorrect GTIN Codes
Biomet is recalling MCK Maximum Congruent Knee System components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1757-2015·2015-06-17
Biomet Recalls Hip Joint Components Due to Incorrect GTIN Labeling
Biomet is recalling 1,315 hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.
Product
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1711-2015·2015-06-10
Synthes Cannulated Drill Bits Recalled for Potential Breakage During Use
Synthes, Inc. is recalling specific lots of Cannulated Drill Bits because they have the potential to break during use. The affected devices were distributed in the US and Canada.
Product
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1637-2015·2015-06-10
Synovis Recalls Vascu-Guard Patches Due to Surface Identification Issues
Synovis is recalling specific Vascu-Guard Peripheral Vascular Patch codes because users reported difficulty distinguishing the smooth from the rough surface.
Product
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1696-2015·2015-06-10
Zimmer Recalls PRI Femoral Impactor Blocks Due to Adhesive Leak Risk
Zimmer, Inc. is recalling 1,689 PRI Femoral Impactor Blocks because uncured adhesive may leak from the device, potentially causing a biological response in patients.
Product
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1695-2015·2015-06-10
Philips Brilliance iCT Computed Tomography X-ray System Recall for Torque Wrench Malfunction
Philips is recalling two Brilliance iCT Computed Tomography X-ray systems because a supplier torque wrench malfunction may have resulted in incorrect fastener torque.
Product
Brilliance iCT Computed Tomography X-ray system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1712-2015·2015-06-10
Elekta Oncentra Brachy software recalled for incorrect dose calculation errors
Elekta, Inc. is recalling Oncentra Brachy radiation therapy planning software because it may calculate incorrect doses for specific regions of interest.
Product
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1704-2015·2015-06-10
Siemens syngo Workflow SLR Recalled for Potential Order Loss
Siemens Medical Solutions USA is recalling 131 syngo Workflow SLR systems because a software defect may cause order loss during restarts, leading to diagnosis delays.
Product
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1701-2015·2015-06-10
Zimmer CAS Recalls Tibial Alignment Guides Due to Spike Breakage Risk
Zimmer CAS is recalling 78 Tibial Alignment Guides because spikes may bend or break during use.
Product
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1703-2015·2015-06-10
Siemens Dade Actin Activated Cephaloplastin Reagent Recalled for Out-of-Range Results
Siemens Healthcare Diagnostics is recalling Dade Actin Activated Cephaloplastin Reagent because assay controls are out of assigned ranges, potentially causing inaccurate APTT test results.
Product
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1694-2015·2015-06-10
Zimmer Recalls 4.5mm Cortical Screws for M/DN Intramedullary Nail System
Zimmer, Inc. is recalling 4.5mm Cortical Screws for the M/DN system because they are not compatible with the device, potentially causing surgical complications.
Product
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1702-2015·2015-06-10
Alcon Custom Pak Recalled for Potential Glove Splits and Holes
Alcon Research, Ltd. is recalling Alcon Custom Paks because the Devon Light Glove component may have splits or holes, which could lead to surgical site infections.
Product
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1700-2015·2015-06-10
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Heparin Activity Failure
Edwards Lifesciences is recalling 978 Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters because they failed internal statistical tests for heparin activity.
Product
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1708-2015·2015-06-10
Siemens Dimension Vista LOCI TSH Test Recalled for Inaccurate Results
Siemens is recalling 2,256 units of the Dimension Vista LOCI TSH test due to a defect that may cause falsely low results.
Product
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1705-2015·2015-06-10
Siemens Medical Software Recall for Missing Image Measurements on Printouts
Siemens Medical Solutions is recalling 167 units of Syngo.via and Syngo.x software because measurements on subsequent images do not appear on printouts.
Product
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1710-2015·2015-06-10
Nidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature
Nidek Inc is recalling 114 EC-5000 Excimer Laser Corneal Surgery Systems because the multi-stage treatment option in the operator's manual was not approved by the FDA.
Product
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1697-2015·2015-06-10
Coreva Recalls ActCel Hemostatic Dressing for Unapproved Marketing Claims
Coreva Health Science is recalling ActCel Hemostatic Dressing because customer literature and websites promoted unapproved uses for controlling bleeding in body cavities.
Product
ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1692-2015·2015-06-10
Smiths Medical Recalls BCI Advisor Vital Signs Monitors for Data Errors
Smiths Medical is recalling 15 BCI Advisor Vital Signs Monitors because their auxiliary serial ports may transmit incorrect data to collection systems.
Product
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1713-2015·2015-06-10
Siemens Factor IX Plasma Reagent Recalled for Inaccurate Low-Range Results
Siemens Healthcare Diagnostics is recalling Factor IX plasma reagents for the BCS/BCS XP system due to erroneously high results at the lower end of the measuring range.
Product
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1709-2015·2015-06-10
AMUSA Recalls 0.9% Sodium Chloride Flush Syringes Due to Incorrect Expiration Date
MRP, LLC dba AMUSA is recalling 200,000 units of 0.9% Sodium Chloride Injection Flush Syringes because the labels display an incorrect expiration date.
Product
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
Category
Medical Device
Distribution
6 states
LowFDA (Devices)·Z-1707-2015·2015-06-10
Ortho-Clinical Diagnostics Recalls VITROS Signal Reagent Due to Labeling Defects
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Signal Reagent, Lot 3082, because the reagent packs may contain blank labels.
Product
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1650-2015·2015-06-03
Philips Brilliance CT 40 Recalled Due to Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance CT 40 systems because the patient couch may unexpectedly descend to its lowest point during an exam.
Product
Brilliance CT 40. 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.
Category
Medical Device
Distribution
0 states

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32901–32925 of 40325