PlainRecalls

2016 Recalls

8,211 recalls · Page 57 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 0 critical, 47 moderate, and 3 lower-severity recalls. The page references 19 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 Sep 21, 2016

Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.

C.R. Bard, Inc.

FDA Devices Moderate Sep 21, 2016

Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft …

Howmedica Osteonics Corp.

FDA Devices Moderate Sep 21, 2016

Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrav…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Sep 21, 2016

Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Mac…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

Arrow International Inc

FDA Devices Moderate Sep 21, 2016

Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrav…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components

Arrow International Inc

FDA Devices Moderate Sep 21, 2016

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital me…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Sep 21, 2016

Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Tra…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.

Arrow International Inc

FDA Devices Moderate Sep 21, 2016

Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1…

Hospira Inc., A Pfizer Company

FDA Devices Moderate Sep 21, 2016

The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact w…

Circulatory Technology Inc

FDA Devices Moderate Sep 21, 2016

CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an unde…

Mentor Texas, LP.

FDA Devices Moderate Sep 21, 2016

Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tiss…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Sep 21, 2016

Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66 Usage: The Transpac Disposable …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07 Us…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Sep 21, 2016

Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Sep 21, 2016

Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

Merge Healthcare, Inc.

FDA Devices Moderate Sep 21, 2016

Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macro…

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an anteg…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Sep 21, 2016

Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Dis…

ICU Medical, Inc.

FDA Devices Low Sep 21, 2016

LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics syst…

Alere San Diego, Inc.

FDA Devices Moderate Sep 21, 2016

CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Nav…

Biosense Webster, Inc.

FDA Devices Moderate Sep 21, 2016

Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument…

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Sep 21, 2016

Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pol…

ICU Medical, Inc.

FDA Devices Low Sep 21, 2016

VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the d…

Biomerieux France Chemin De L'Or

FDA Devices Moderate Sep 21, 2016

Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is a…

ICU Medical, Inc.

FDA Devices Low Sep 21, 2016

Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

FDA Devices Moderate Sep 21, 2016

Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.

C.R. Bard, Inc.

FDA Devices Moderate Sep 21, 2016

Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an un…

Mentor Texas, LP.

FDA Devices Moderate Sep 21, 2016

TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and qu…

Thermo Finnigan LLC

FDA Devices Moderate Sep 21, 2016

LAUREATE World Phaco System

Alcon Research, Ltd.

FDA Devices Moderate Sep 21, 2016

AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters …

AirStrip Technologies, Inc.

FDA Devices Moderate Sep 21, 2016

Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is …

ICU Medical, Inc.

FDA Devices Moderate Sep 21, 2016

Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Sep 21, 2016

Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous acce…

Arrow International Inc

FDA Devices Moderate Sep 21, 2016

RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Sep 21, 2016

Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the…

Sysmex America Inc

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

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.