PlainRecalls

2016 Recalls

6,806 recalls · Page 29 of 137

2016 Recall Year Insight

Federal agencies issued 6,806 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.11% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 18.6 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 137 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 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, NHTSA, or USDA FSIS 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

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.

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 …

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…

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 st…

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 p…

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.

FDA Devices Moderate Oct 26, 2016

Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Calix P PEEK Lumbar System, PLIF Trial

X Spine Systems Inc

FDA Devices Moderate Oct 26, 2016

Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room

Windstone Medical Packaging, Inc.

FDA Devices Moderate Oct 26, 2016

VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, I…

Ortho-Clinical Diagnostics

FDA Devices Moderate Oct 26, 2016

C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 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 + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2016