PlainRecalls

2016 Recalls

8,148 recalls · Page 154 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 2 critical, 48 moderate, and 0 lower-severity recalls. The page references 19 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (48), FDA Drug (2), 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 Drug Moderate Feb 10, 2016

Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68

Pfizer Inc.

FDA Drug Moderate Feb 10, 2016

Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157

Perrigo Company PLC

FDA Devices Moderate Feb 10, 2016

Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging ap…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasm…

Horiba Instruments Inc

FDA Devices Moderate Feb 10, 2016

HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chr…

Instrumentation Laboratory Co.

FDA Devices Moderate Feb 10, 2016

BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitati…

bioMerieux, Inc.

FDA Devices Moderate Feb 10, 2016

INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular a…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional proc…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

Baxter Corporation Englewood

FDA Devices Moderate Feb 10, 2016

Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and intervent…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascul…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic,…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascul…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and …

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.

JosNoe Medical, Inc.

FDA Devices Moderate Feb 10, 2016

Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument

Smith & Nephew, Inc., Endoscopy Div.

FDA Devices Moderate Feb 10, 2016

INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascu…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and pla…

Horiba Instruments Inc

FDA Devices Moderate Feb 10, 2016

INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascu…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and ur…

Horiba Instruments Inc

FDA Devices Moderate Feb 10, 2016

Synthes Small Electric Drive (SED). For use in general traumatology.

The Anspach Effort, Inc.

FDA Devices Moderate Feb 10, 2016

INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascu…

Philips Electronics North America Corporation

FDA Devices Critical Feb 10, 2016

Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pr…

Draeger Medical, Inc.

FDA Devices Critical Feb 10, 2016

Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volu…

Draeger Medical, Inc.

FDA Devices Moderate Feb 10, 2016

Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument

Smith & Nephew, Inc., Endoscopy Div.

FDA Devices Moderate Feb 10, 2016

ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Feb 10, 2016

Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest populat…

Resmed Corporation

FDA Devices Moderate Feb 10, 2016

MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] …

Owens & Minor Distribution, Inc.

FDA Devices Moderate Feb 10, 2016

ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colo…

Horiba Instruments Inc

FDA Devices Moderate Feb 10, 2016

Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital s…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular …

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascul…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma …

Horiba Instruments Inc

FDA Devices Moderate Feb 10, 2016

INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurova…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Me…

Acist Medical Systems

FDA Devices Moderate Feb 10, 2016

ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

Global Healthcare Inc

FDA Devices Moderate Feb 10, 2016

UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular ima…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular a…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system…

Olympus Corporation of the Americas

FDA Devices Moderate Feb 10, 2016

Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic an…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interven…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitat…

bioMerieux, Inc.

FDA Devices Moderate Feb 10, 2016

MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. …

Owens & Minor Distribution, Inc.

FDA Devices Moderate Feb 10, 2016

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

Radiometer America Inc

FDA Devices Moderate Feb 10, 2016

Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-…

Mindray DS USA, Inc. dba Mindray North America

FDA Devices Moderate Feb 10, 2016

INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascu…

Philips Electronics North America Corporation

FDA Devices Moderate Feb 10, 2016

INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascul…

Philips Electronics North America Corporation

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