PlainRecalls

2016 Recalls

Compiled from official public sources by the editorial team.

8,211 recalls · Page 15 of 165

2016 Recall Year Insight

Federal agencies issued 8,211 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.07% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 22.5 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 165 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 8 critical, 35 moderate, and 7 lower-severity recalls. The page references 30 distinct recalling firms operating in 6 distinct product categories, with 38 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (30), NHTSA (8), CPSC (7), 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.

← 2015 2017 →
FDA Devices Critical Dec 7, 2016

Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T1575…

Greatbatch Medical
FDA Devices Moderate Dec 7, 2016

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

B. Braun Medical, Inc.
FDA Devices Low Dec 7, 2016

Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 2600…

MicroPort Orthopedics Inc.
FDA Devices Moderate Dec 7, 2016

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to…

Merge Healthcare, Inc.
FDA Devices Moderate Dec 7, 2016

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

Terumo BCT, Inc.
FDA Devices Moderate Dec 7, 2016

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Synthes (USA) Products LLC
FDA Devices Low Dec 7, 2016

Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the cons…

MicroPort Orthopedics Inc.
FDA Devices Moderate Dec 7, 2016

FMsealer Open Shears. Model FM3001

Domain Surgical, Inc.
FDA Devices Moderate Dec 7, 2016

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the v…

Teleflex Medical
FDA Devices Moderate Dec 7, 2016

MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is…

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Dec 7, 2016

Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and …

Spectranetics Corporation
FDA Devices Moderate Dec 7, 2016

Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, a…

Hamilton Medical, Inc.
FDA Devices Moderate Dec 7, 2016

OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiratio…

Teleflex Medical
FDA Devices Moderate Dec 7, 2016

Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Cath…

Spectranetics Corporation
FDA Devices Moderate Dec 7, 2016

ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacem…

ConforMIS, Inc.
FDA Devices Moderate Dec 7, 2016

Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Elekta, Inc.
FDA Devices Moderate Dec 7, 2016

Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Elekta, Inc.
FDA Devices Low Dec 7, 2016

Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450,…

MicroPort Orthopedics Inc.
FDA Devices Moderate Dec 7, 2016

V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speak…

Baxter Healthcare Corp.
FDA Devices Low Dec 7, 2016

Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 3…

MicroPort Orthopedics Inc.
FDA Devices Moderate Dec 7, 2016

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization proced…

Merge Healthcare, Inc.
FDA Devices Moderate Dec 7, 2016

ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow …

Teleflex Medical
FDA Devices Moderate Dec 7, 2016

sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Ident…

Baxter Healthcare Corp.
FDA Devices Low Dec 7, 2016

Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 3669…

MicroPort Orthopedics Inc.
FDA Devices Moderate Dec 7, 2016

MISAGO RX Self Expanding Peripheral Stem

Terumo Medical Corp
FDA Devices Moderate Dec 7, 2016

Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 0008…

Baxter Healthcare Corp.
FDA Devices Moderate Dec 7, 2016

ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunctio…

Spectranetics Corporation
FDA Devices Low Dec 7, 2016

Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the con…

MicroPort Orthopedics Inc.
FDA Devices Moderate Dec 7, 2016

ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 1…

Sorin Group USA, Inc.
FDA Devices Moderate Dec 7, 2016

ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspira…

Teleflex Medical
CPSC Moderate Dec 7, 2016

Playworld Recalls Stainless Steel Playground Slides Due to Amputation Hazard (Recall Alert)

Horizon Industries, of Columbia, Pa
CPSC Moderate Dec 7, 2016

Schurman Retail Group Recalls Gift Boxes Due to Risk of Mold Exposure
NHTSA Critical Dec 7, 2016

STERLING 2008: ELECTRICAL SYSTEM:ALTERNATOR/GENERATOR/REGULATOR

STERLING
CPSC Moderate Dec 6, 2016

Atrium Recalls SafeHarbor Windows Due to Impact Injury Hazard

Atrium Windows and Doors Inc., of Welcome, N.C.
CPSC Moderate Dec 6, 2016

Target Reannounces Recall of Menorahs Due to Fire Hazard
NHTSA Critical Dec 6, 2016

SUZUKI 2012-2013: ELECTRICAL SYSTEM:ALTERNATOR/GENERATOR/REGULATOR

SUZUKI
NHTSA Moderate Dec 5, 2016

FORD,LINCOLN 2013-2016: SEAT BELTS:FRONT

FORD,LINCOLN
NHTSA Critical Dec 5, 2016

FORD 2017: SEATS:MID/REAR ASSEMBLY

FORD
NHTSA Critical Dec 5, 2016

PETERBILT 2017: EXTERIOR LIGHTING:BRAKE LIGHTS:SWITCH

PETERBILT
NHTSA Critical Dec 2, 2016

CHEVROLET 2017: AIR BAGS:SIDE/WINDOW

CHEVROLET
NHTSA Critical Dec 2, 2016

CHEVROLET 2010-2014: ENGINE AND ENGINE COOLING:COOLING SYSTEM:FAN

CHEVROLET
NHTSA Moderate Dec 2, 2016

MITSUBISHI 2011-2016: STRUCTURE:BODY:HATCHBACK/LIFTGATE:HINGE AND ATTACHMENTS

MITSUBISHI
CPSC Moderate Dec 1, 2016

Baby Bath Seats/Chairs Recalled Due to Drowning Hazard; Made by Lexibook (Recall Alert)

Lexibook S.A., of France
CPSC Moderate Dec 1, 2016

LED Lamps Recalled by Technical Consumer Products Due to Electrical Shock Hazard; Sold Exclusively at Habitat for Humanity in California
CPSC Moderate Dec 1, 2016

Valspar Recalls Wood Cleaner and Wood Brightener Products Due to Chemical Hazard

The Valspar Corporation, Cabot brand owner, of Minneapolis, Minn.
FDA Food Moderate Nov 30, 2016

BM Westco Sup-R-Roll Donut Mix, 50#

CSM Bakery Products NA
FDA Food Critical Nov 30, 2016

Blue Bunny Ice Cream Hoppin' Holidoodle ice cream 46 fl. oz. UPC 070640014644 and UPC 070640014651 (high altitude).

Wells Enterprises, Inc.
FDA Food Moderate Nov 30, 2016

Buffets Corn Muffin Mix, 30# Bag

CSM Bakery Products NA
FDA Food Low Nov 30, 2016

HCG Plus. 2oz HCG Drops. Blue Glass

Infiniti Creations, LLC
FDA Food Moderate Nov 30, 2016

Copack Choccupcake Base 51.5#

CSM Bakery Products NA

Nearby Recall Years

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

2014 2015 2017 2018 2019

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2016 across the FDA, CPSC 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 July 2026.