PlainRecalls

2016 Recalls

8,211 recalls · Page 34 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 5 critical, 45 moderate, and 0 lower-severity recalls. The page references 13 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 Oct 26, 2016

Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis…

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 26, 2016

25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Synergetics Inc

FDA Devices Moderate Oct 26, 2016

Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Calix T PEEK Lumbar System, TLIF Trial

X Spine Systems Inc

FDA Devices Moderate Oct 26, 2016

Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

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

Merge Healthcare, Inc.

FDA Devices Moderate Oct 26, 2016

Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for gen…

Windstone Medical Packaging, Inc.

FDA Devices Critical Oct 26, 2016

Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual…

Vascular Solutions, Inc.

FDA Devices Critical Oct 26, 2016

Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen …

Teleflex Medical

FDA Devices Moderate Oct 26, 2016

Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has a…

ConMed Corporation

FDA Devices Moderate Oct 26, 2016

Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

SDMS (SenTec Digital Monitoring System)

SenTec AG

FDA Devices Moderate Oct 26, 2016

Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for…

US Endoscopy Group Inc

FDA Devices Moderate Oct 26, 2016

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, an…

ConMed Corporation

FDA Devices Moderate Oct 26, 2016

Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Critical Oct 26, 2016

Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lu…

Vascular Solutions, Inc.

FDA Devices Moderate Oct 26, 2016

Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, lap…

ConMed Corporation

FDA Devices Moderate Oct 26, 2016

Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating ro…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience cus…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Critical Oct 26, 2016

HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of deat…

Heartware, Inc.

FDA Devices Moderate Oct 26, 2016

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

Olympus Corporation of the Americas

FDA Devices Moderate Oct 26, 2016

Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixat…

Hand Biomechanics Lab Inc

FDA Devices Moderate Oct 26, 2016

Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Critical Oct 26, 2016

Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access cathete…

Vascular Solutions, Inc.

FDA Devices Moderate Oct 26, 2016

Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, 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.