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 11 critical, 35 moderate, and 4 lower-severity recalls. The page references 34 distinct recalling firms operating in 6 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (30), FDA Drug (7), CPSC (6), 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 Drug Low Nov 16, 2016

Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

FDA Drug Moderate Nov 16, 2016

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054

Sandoz Inc

FDA Drug Low Nov 16, 2016

Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Drug Moderate Nov 16, 2016

Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

FDA Drug Low Nov 16, 2016

Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

FDA Drug Low Nov 16, 2016

Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

FDA Drug Moderate Nov 16, 2016

Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

FDA Devices Moderate Nov 16, 2016

GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corp.

FDA Devices Moderate Nov 16, 2016

Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Covidien LLC

FDA Devices Moderate Nov 16, 2016

TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

Medimaps Group

FDA Devices Moderate Nov 16, 2016

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.

Hospira Inc.

FDA Devices Critical Nov 16, 2016

Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No. FA-71300-25V09 FA-71350-25V16 FA-71400-25V10 FA-71425-35V13 FA-71475-30V16 FA-71300-25V12 FA-71350-25V17 FA-71400-25V11 FA-71425-35V15 FA-71475-30V18 FA-71300-25V13 FA-71350-

Micro Therapeutics Inc, Dba Ev3 Neurovascular

FDA Devices Critical Nov 16, 2016

Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06

Micro Therapeutics Inc, Dba Ev3 Neurovascular

FDA Devices Critical Nov 16, 2016

X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02

Micro Therapeutics Inc, Dba Ev3 Neurovascular

FDA Devices Moderate Nov 16, 2016

OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operatin

Trumpf Medical Systems, Inc.

FDA Devices Moderate Nov 16, 2016

SOMATOM Definition AS system, x-ray, tomography, computed

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 16, 2016

ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

Reshape Medical Inc

FDA Devices Moderate Nov 16, 2016

Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.

Maquet Medical Systems USA

FDA Devices Moderate Nov 16, 2016

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.

Hospira Inc.

FDA Devices Moderate Nov 16, 2016

ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.

Abbott Laboratories

FDA Devices Moderate Nov 16, 2016

Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Nov 16, 2016

X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.

C.R. Bard, Inc.

FDA Devices Moderate Nov 16, 2016

LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Nov 16, 2016

SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

Akita Sumitomo Bakelite Co., Ltd.

FDA Devices Moderate Nov 16, 2016

SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

Akita Sumitomo Bakelite Co., Ltd.

FDA Devices Moderate Nov 16, 2016

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

AtriCure, Inc.

FDA Devices Moderate Nov 16, 2016

Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118. Product Usage: The cylinders are used to lock the surgical table in place.

Schaerer Medical USA Inc

FDA Devices Moderate Nov 16, 2016

Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Covidien LLC

FDA Devices Critical Nov 16, 2016

Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of

Micro Therapeutics Inc, Dba Ev3 Neurovascular

FDA Devices Moderate Nov 16, 2016

Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.

Zimmer Surgical Inc

FDA Devices Moderate Nov 16, 2016

Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. Reprocess

Stryker Sustainability Solutions

FDA Devices Moderate Nov 16, 2016

SOMATOM Definition Flash system, x-ray, tomography, computed

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Nov 16, 2016

NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart.

Baylis Medical Corp *

FDA Devices Moderate Nov 16, 2016

The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.

Schaerer Medical USA Inc

FDA Devices Moderate Nov 16, 2016

catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405622 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Bupivacaine HCL (0.75%) with Dextrose (8.25%), 2 mL (Marcaine) Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog # 405623 BD Spinal Anesthesia Tray 25G x 3.5 in. BD" Quincke Spinal Needle Lidocaine HCL (5%) with Dextrose (7.5%), 2 mL catalog #405624 BD Spinal A

Becton Dickinson & Company

FDA Devices Critical Nov 16, 2016

FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.

SentreHeart Inc

FDA Devices Moderate Nov 16, 2016

Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

Covidien LLC

CPSC No agency class Nov 16, 2016

Skidders Footwear Recalls Children's Shoes Due to Laceration Hazard; Sold Exclusively at Meijer Stores

Skidders Footwear Inc., of New York

NHTSA No agency class Nov 16, 2016

MERCEDES-BENZ 2016-2017: SEAT BELTS

MERCEDES-BENZ

CPSC No agency class Nov 15, 2016

Gates Recalls ATV and UTV Clutches Due to Laceration and Injury Hazards (Recall Alert)

Gates Canada Inc., of Canada

CPSC No agency class Nov 15, 2016

Projection Night Lights Recalled by LTD Commodities and The Lakeside Collection Due to Shock and Fire Hazards (Recall Alert)

Wenzhou Weihao Light Industry Co. LTD, of China

NHTSA No agency class Nov 15, 2016

FREIGHTLINER 2017: TIRES:TREAD/BELT

FREIGHTLINER

USDA FSIS Moderate Nov 15, 2016

Piccadilly Fine Foods Recalls Beef Shepherd’s Pie Due To Misbranding and Undeclared Allergens

CPSC No agency class Nov 14, 2016

Hammerhead Off-Road Recalls Fun-Karts Due to Fuel Leak and Fire Hazards (Recall Alert)

Hammerhead Off-Road, of Flower Mound, Texas

USDA FSIS Critical Nov 12, 2016

Schnuck Markets Inc. Recalls Ready-To-Eat Chicken Breast Products That May Be Undercooked

Schnuck Markets, Inc. SLNP

CPSC No agency class Nov 10, 2016

Kidde Recalls Combination Smoke/CO Alarms Due to Alarm Failure

CPSC No agency class Nov 10, 2016

L.D. Kichler Recalls Ceiling Fixtures Due to Fire Hazard

NHTSA No agency class Nov 10, 2016

BENTLEY 2017: SEATS

BENTLEY

NHTSA No agency class Nov 10, 2016

KIA 2008-2009: ELECTRICAL SYSTEM:WIRING

KIA

NHTSA No agency class Nov 10, 2016

DODGE,JEEP 2016: FUEL SYSTEM, GASOLINE:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS

DODGE,JEEP

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.