PlainRecalls

2016 Recalls

Compiled from official public sources by the editorial team.

8,211 recalls · Page 114 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 13 critical, 36 moderate, and 1 lower-severity recalls. The page references 21 distinct recalling firms operating in 5 distinct product categories, with 42 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (37), NHTSA (8), CPSC (5), 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 Moderate May 18, 2016

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distrib…

Applied Medical Resources Corp
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Triglycerides (TRIG)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

Ascom US, INC.
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bra…

Covidien LLC
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Direct HDL Cholesterol (AHDL)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Uric Acid (URCA)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Novarad Corporation
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implanta…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

Neusoft Medical Systems Co., Ltd.
FDA Devices Moderate May 18, 2016

Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or pla…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and contro…

C.R. Bard, Inc.
FDA Devices Moderate May 18, 2016

Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175

Stryker Sustainability Solutions
FDA Devices Moderate May 18, 2016

Dimension Vista Assays: Enzymatic Creatine (ECRE)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot Cin…

Stryker Corporation
FDA Devices Moderate May 18, 2016

Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument …

Bradshaw Medical Inc.
FDA Devices Moderate May 18, 2016

Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is de…

Hamilton Medical, Inc.
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: Lactate

Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Low May 18, 2016

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is …

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Dimension Assays: Uric Acid (URCA)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acut…

Medtronic
FDA Devices Moderate May 18, 2016

Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..

Stryker Sustainability Solutions
FDA Devices Moderate May 18, 2016

Advia Chemistry Assay: LDL Cholesterol, Direct

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY ENZYMATIC CREATININE_2

Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use, implan…

Baxter Healthcare Corp.
FDA Devices Moderate May 18, 2016

Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute…

Medtronic
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Car…

Biomerieux Inc
CPSC Moderate May 18, 2016

phil&teds Recalls Dash Strollers Due to Risk of Injury

phil&teds, of Fort Collins, Colo.
CPSC Moderate May 17, 2016

Pacific Cycle Recalls Infant Bicycle Helmets Due to Choking and Magnet Ingestion Hazards; Sold Exclusively at Target
CPSC Moderate May 17, 2016

Target Recalls Menorahs Due to Fire Hazard
NHTSA Critical May 17, 2016

KIA 2013: SEAT BELTS:FRONT:RETRACTOR

KIA
NHTSA Critical May 17, 2016

BMW 2011: POWER TRAIN:DRIVELINE:DRIVESHAFT

BMW
NHTSA Critical May 17, 2016

MERCEDES-BENZ 2016: POWER TRAIN:DRIVELINE:DRIVESHAFT

MERCEDES-BENZ
NHTSA Critical May 16, 2016

FIAT 2013-2016: ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY

FIAT
NHTSA Critical May 16, 2016

FIAT 2012-2016: POWER TRAIN:MANUAL TRANSMISSION

FIAT
NHTSA Critical May 16, 2016

RAM 2016: POWER TRAIN:AXLE ASSEMBLY:AXLE SHAFT

RAM
NHTSA Moderate May 16, 2016

CHRYSLER,DODGE 2016: SEATS:MID/REAR ASSEMBLY

CHRYSLER,DODGE
NHTSA Critical May 16, 2016

RAM 2013-2016: EQUIPMENT

RAM
CPSC Moderate May 12, 2016

Hobby Lobby Recalls Infant Pacifier Holders Due to Choking Hazard
CPSC Moderate May 12, 2016

Hobby Lobby Recalls Infant Rattles Due to Choking Hazard

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 August 2026.