PlainRecalls

2016 Recalls

8,148 recalls · Page 144 of 163

2016 Recall Year Insight

Federal agencies issued 8,148 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 9.71% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 22.3 recalls per day across the FDA, CPSC, 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 163 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 1 critical, 48 moderate, and 1 lower-severity recalls. The page references 12 distinct recalling firms operating in 1 distinct product categories, with 50 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Mar 2, 2016

Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, st…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 2, 2016

NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile beari…

Zimmer Biomet, Inc.

FDA Devices Low Mar 2, 2016

CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Pe…

Sorin Group USA, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

Philips Electronics North America Corporation

FDA Devices Moderate Mar 2, 2016

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-t…

Cook Inc.

FDA Devices Moderate Mar 2, 2016

CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

Philips Electronics North America Corporation

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD P/N 70-0050-A22) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluorosc…

Regulatory Insight, Inc

FDA Devices Critical Mar 2, 2016

Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

Draeger Medical, Inc.

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Philips Healthcare IntelliVue Info Center iX, A.0 866023

Philips Electronics North America Corporation

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/pol…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer vari…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and …

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, …

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hi…

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 2, 2016

EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is c…

EKOS Corporation

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Profile Balloon is intended to provide gas…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light micro…

Leica Microsystems, Inc.

FDA Devices Moderate Mar 2, 2016

Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope

Integrated Medical Systems Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-0050-912) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The EndoVive 3s Low Profile Balloon is intended to provide gast…

Xeridiem Mediem Medical Devices Inc

FDA Devices Moderate Mar 2, 2016

Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Stryker Howmedica Osteonics 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: CPSC + NHTSA — consumer product and vehicle recall feeds for 2016