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, 42 moderate, and 3 lower-severity recalls. The page references 32 distinct recalling firms operating in 7 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (39), CPSC (4), FDA Drug (3), 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 Moderate Dec 14, 2016

Amphibious Trauma Kit - Product Code 85-0639, North American Rescue

North American Rescue LLC.

FDA Drug Moderate Dec 14, 2016

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.

Fallon Wellness Pharmacy, L.L.C.

FDA Drug Low Dec 14, 2016

5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

Hospira Inc.

FDA Devices Critical Dec 14, 2016

5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001

SynCardia Systems Inc.

FDA Devices Moderate Dec 14, 2016

RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended u

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Dec 14, 2016

Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.

Encore Medical, Lp

FDA Devices Moderate Dec 14, 2016

Brilliance 64 728231 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 14, 2016

TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

DeRoyal Industries Inc

FDA Devices Moderate Dec 14, 2016

BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Critical Dec 14, 2016

Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.

Centurion Medical Products Corporation

FDA Devices Moderate Dec 14, 2016

Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 14, 2016

SOMATOM Force, System x-ray, tomography, computed

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Dec 14, 2016

Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material

Ivoclar Vivadent, Inc.

FDA Devices Moderate Dec 14, 2016

Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

Elana, Inc.

FDA Devices Moderate Dec 14, 2016

Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

Tornier, Inc

FDA Devices Moderate Dec 14, 2016

AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

Amd-Ritmed, Inc.

FDA Devices Low Dec 14, 2016

Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

OraSure Technologies, Inc.

FDA Devices Moderate Dec 14, 2016

ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 14, 2016

Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; a

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Dec 14, 2016

Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968 00; C-Section Drape with Pouch and Fenestration (Non-Sterile), Product Code 44977 NS; C-Section Drape with Pouch and Fenestration (Sterile), Product Code 44978 00 Product Usage: A

Halyard Health, Inc

FDA Devices Moderate Dec 14, 2016

Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

Sorin Group USA, Inc.

FDA Devices Moderate Dec 14, 2016

Magnesium on RX Imola analyser IVD

Randox Laboratories, Limited

FDA Devices Moderate Dec 14, 2016

LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

DePuy Orthopaedics, Inc.

FDA Devices Moderate Dec 14, 2016

BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 The BioFlo PICCs with ENDEXO Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the admin

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Dec 14, 2016

Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Dec 14, 2016

Ingenuity Core 728321 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 14, 2016

UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.

Ultradent Products, Inc.

FDA Devices Moderate Dec 14, 2016

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.

Merge Healthcare, Inc.

FDA Devices Moderate Dec 14, 2016

MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.

Thayer Intellectual Property, Inc.

FDA Devices Moderate Dec 14, 2016

PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

DeRoyal Industries Inc

FDA Devices Moderate Dec 14, 2016

Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Dec 14, 2016

Ingenuity CT 728326 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 14, 2016

Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System

Olympus Scientific Solutions Americas

FDA Devices Moderate Dec 14, 2016

IQon Spectral CT is a Computed Tomography X-Ray System 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 Dec 14, 2016

Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

Ivoclar Vivadent, Inc.

FDA Devices Moderate Dec 14, 2016

Ingenuity Core 128 728323

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 14, 2016

Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model 37761) and an antenna.

Medtronic Neuromodulation

FDA Devices Moderate Dec 14, 2016

3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring Sys

3M Company - Health Care Business

FDA Devices Moderate Dec 14, 2016

Brilliance 64 728232 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 14, 2016

Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material

Ivoclar Vivadent, Inc.

FDA Devices Moderate Dec 14, 2016

Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood

Angiodynamics Inc. (Navilyst Medical Inc.)

FDA Devices Moderate Dec 14, 2016

Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have

Merge Healthcare, Inc.

CPSC No agency class Dec 14, 2016

Trek Recalls Bicycle Lights Due to Injury Hazard

NHTSA No agency class Dec 14, 2016

MERCEDES-BENZ 2014: SERVICE BRAKES, HYDRAULIC:POWER ASSIST:VACUUM:HOSES, LINES/PIPING, AND FITTINGS

MERCEDES-BENZ

NHTSA No agency class Dec 14, 2016

MERCEDES-BENZ 2014-2016: STEERING:ELECTRIC POWER ASSIST SYSTEM

MERCEDES-BENZ

CPSC No agency class Dec 13, 2016

Chicken Toys Recalled by Bingo Deals Due to Choking Hazard (Recall Alert)

Bingo Deals Corp, of Monroe, N.Y.

CPSC No agency class Dec 13, 2016

Cuisinart Food Processors Recalled by Conair Due to Laceration Hazard

Conair Corp., of Stamford, Conn., owner of the Cuisinart brand

CPSC No agency class Dec 13, 2016

World Trading Recalls Orbit Self-Balancing Scooters/Hoverboards Due to Fire Hazard; Sold by Evine

USDA FSIS Low Dec 12, 2016

King Meat Services, Inc. Recalls Beef Products Due To Misbranding

King Meat Service Inc.

NHTSA No agency class Dec 9, 2016

LAND ROVER 2016-2017: SUSPENSION:FRONT:CONTROL ARM:LOWER ARM

LAND ROVER

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.