PlainRecalls

2016 Recalls

8,148 recalls · Page 113 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 7 critical, 42 moderate, and 1 lower-severity recalls. The page references 17 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 May 18, 2016

Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are …

St Jude Medical Inc.

FDA Devices Moderate May 18, 2016

Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Dimension Assays: Triglycerides (TGL)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Stanmore Implants Worldwide Ltd.

FDA Devices Moderate May 18, 2016

ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO metho…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, impla…

Baxter Healthcare Corp.

FDA Devices Moderate May 18, 2016

Dimension Assays: ENZYMATIC CREATININE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo…

Covidien LLC

FDA Devices Critical May 18, 2016

Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with t…

Medtronic

FDA Devices Critical May 18, 2016

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 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-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Ca…

Biomerieux Inc

FDA Devices Moderate May 18, 2016

Dimension Assays: Direct HDL Cholesterol (AHDL)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate May 18, 2016

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

Stryker Corporation

FDA Devices Moderate May 18, 2016

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

Atlas Spine, Inc.

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

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