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 15 distinct recalling firms operating in 4 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (46), CPSC (2), NHTSA (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, 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

General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.

Merge Healthcare, Inc.

FDA Devices Moderate Oct 26, 2016

Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Fusion Workstation.; Indicated for the transmission and review of radiological images.

Merge Healthcare, Inc.

FDA Devices Moderate Oct 26, 2016

Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

D & C Kit, Kit number CMP1466 and CMP1466(A 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 Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Synergetics Inc

FDA Devices Moderate Oct 26, 2016

Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.

Zimmer Biomet, Inc.

FDA Devices Moderate Oct 26, 2016

Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses

Ethicon Endo-Surgery Inc

FDA Devices Moderate Oct 26, 2016

Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Oct 26, 2016

Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwi

Philips Electronics North America Corporation

FDA Devices Moderate Oct 26, 2016

Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 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

Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Critical Oct 26, 2016

Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.

Leonhard Lang Medizintechnik GmbH

FDA Devices Moderate Oct 26, 2016

RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocat

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

FDA Devices Moderate Oct 26, 2016

Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

Tearscience, Inc

FDA Devices Moderate Oct 26, 2016

Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

CPSC No agency class Oct 26, 2016

Hearth & Home Technologies Recalls Wood Stoves Due to Injury Hazard (Recall Alert)

Hearth & Home Technologies of Lakeville, Minn.

CPSC No agency class Oct 26, 2016

H-E-B Recalls Star Chairs Due to Fall Hazard

Parkway Manufacturing and Trading Company, of San Antonio, Texas

NHTSA No agency class Oct 26, 2016

CHEVROLET 2016: AIR BAGS:SIDE/WINDOW

CHEVROLET

NHTSA No agency class Oct 26, 2016

FORD 2015-2017: ENGINE AND ENGINE COOLING:COOLING SYSTEM:HOSES/LINES/PIPING/FITTINGS

FORD

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.