PlainRecalls

2016 Recall Year Insight

Federal agencies issued 8,349 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.00% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 22.9 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 167 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2016.

On this page of 50 records, severity classification shows 5 critical, 44 moderate, and 1 lower-severity recalls. The page references 21 distinct recalling firms operating in 1 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2016 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Aug 31, 2016

Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.

Merz North America, Inc.

FDA Devices Moderate Aug 31, 2016

Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Cook Inc.

FDA Devices Critical Aug 31, 2016

Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the P

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

Merge Healthcare, Inc.

FDA Devices Moderate Aug 31, 2016

OEC UroView 2800, fluoroscopic x-ray system

GE OEC Medical Systems, Inc

FDA Devices Moderate Aug 31, 2016

Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.

Richard Wolf Medical Instruments Corp.

FDA Devices Moderate Aug 31, 2016

Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

American National Mfg Inc

FDA Devices Moderate Aug 31, 2016

BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

Bovie Medical Corporation

FDA Devices Moderate Aug 31, 2016

SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been vali

Tecan US, Inc.

FDA Devices Moderate Aug 31, 2016

Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency.

Cook Inc.

FDA Devices Moderate Aug 31, 2016

Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and Alp

Tecan US, Inc.

FDA Devices Moderate Aug 31, 2016

Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

Medtronic Neuromodulation

FDA Devices Moderate Aug 31, 2016

Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite

Tecan US, Inc.

FDA Devices Moderate Aug 31, 2016

Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricu

Medtronic Inc., Cardiac Rhythm and Heart Failure

FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

Vision RT Ltd

FDA Devices Moderate Aug 31, 2016

DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.

Medtronic Neuromodulation

FDA Devices Moderate Aug 31, 2016

Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated

Tecan US, Inc.

FDA Devices Moderate Aug 31, 2016

Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic

Cook Inc.

FDA Devices Moderate Aug 31, 2016

Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for

Tecan US, Inc.

FDA Devices Low Aug 31, 2016

Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Aug 31, 2016

BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

Bovie Medical Corporation

FDA Devices Critical Aug 31, 2016

Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not

Alere San Diego, Inc.

FDA Devices Critical Aug 31, 2016

Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment

Cook Inc.

FDA Devices Moderate Aug 31, 2016

Brilliance 16, Model number 728246 Product Usage: 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.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhy

Medtronic Inc., Cardiac Rhythm and Heart Failure

FDA Devices Moderate Aug 31, 2016

CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.

INNOKAS MEDICAL OY

FDA Devices Critical Aug 31, 2016

INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that cause coagulation to begin. The test strip area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. Intended to be used for the dispersion and return to the electrosurgical generator.

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.

Cook Inc.

FDA Devices Critical Aug 31, 2016

Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metal

Cook Inc.

FDA Devices Moderate Aug 31, 2016

Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Cook Inc.

FDA Devices Moderate Aug 31, 2016

SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 31, 2016

BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

Bovie Medical Corporation

FDA Devices Moderate Aug 31, 2016

Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.

Encore Medical, Lp

FDA Devices Moderate Aug 31, 2016

SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 31, 2016

Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.

Cook Inc.

FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

OEC 9800, fluoroscopic x-ray system

GE OEC Medical Systems, Inc

FDA Devices Moderate Aug 31, 2016

Ingenuity Core, Model number 728321 Product Usage: 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.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

Baxter Healthcare Corp.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2016 with 2015 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2016

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2016 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.