PlainRecalls

2016 Recall Year Insight

Federal agencies issued 8,349 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.00% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 22.9 recalls per day across the FDA, CPSC, USDA FSIS, 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 167 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 3 critical, 47 moderate, and 0 lower-severity recalls. The page references 10 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, USDA FSIS, 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

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 lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible with various

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, laparoscopic cholecystectomy and other laparoscopic procedures

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 room

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 custom kits used for general surgery in hospital operating room

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 death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

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 fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboa

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 catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment. The Twin-Pass catheter has a working length of 135cm and is compatible

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.

FDA Devices Moderate Oct 26, 2016

Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used

Ortho-Clinical Diagnostics

FDA Devices Moderate Oct 26, 2016

Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.

Osteogenics Biomedical, Inc.

FDA Devices Moderate Oct 26, 2016

Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Synergetics Inc

FDA Devices Moderate Oct 26, 2016

Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

Randox Laboratories Ltd.

FDA Devices Moderate Oct 26, 2016

Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Minor Ortho Pack, Kit number 002646-12 and 002646-13 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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2016

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2016 across the FDA, CPSC, USDA FSIS 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 September 2026.