PlainRecalls

2016 Recalls

6,806 recalls · Page 78 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 0 critical, 50 moderate, and 0 lower-severity recalls. The page references 23 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (42), CPSC (8), 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 Jul 6, 2016

Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not…

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray s…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris Sys…

CareFusion 303, Inc.

FDA Devices Moderate Jul 6, 2016

Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is n…

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubation…

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Fing…

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

FDA Devices Moderate Jul 6, 2016

Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid…

Medical Depot Inc.

FDA Devices Moderate Jul 6, 2016

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to …

Hospira Inc.

FDA Devices Moderate Jul 6, 2016

*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEH…

Hospira Inc.

FDA Devices Moderate Jul 6, 2016

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Circulatory Technology Inc

FDA Devices Moderate Jul 6, 2016

Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.

Medical Depot Inc.

FDA Devices Moderate Jul 6, 2016

Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.

Medical Depot Inc.

FDA Devices Moderate Jul 6, 2016

Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing…

Integra LifeSciences Corp.

FDA Devices Moderate Jul 6, 2016

Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach an…

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

MOSAIQ Oncology Information System

Elekta, Inc.

FDA Devices Moderate Jul 6, 2016

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arth…

Smith & Nephew, Inc.

FDA Devices Moderate Jul 6, 2016

IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a d…

CMP Industries, Llc

FDA Devices Moderate Jul 6, 2016

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid ar…

Smith & Nephew, Inc.

FDA Devices Moderate Jul 6, 2016

Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatom…

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDAR…

Hospira Inc.

FDA Devices Moderate Jul 6, 2016

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid ar…

Smith & Nephew, Inc.

FDA Devices Moderate Jul 6, 2016

Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system inte…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray sys…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample colle…

Dynarex Corporation

FDA Devices Moderate Jul 6, 2016

Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determ…

Beckman Coulter Inc.

FDA Devices Moderate Jul 6, 2016

Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray syste…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; …

Hospira Inc.

FDA Devices Moderate Jul 6, 2016

Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intend…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Jul 6, 2016

Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is …

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

CENTURION Vision System

Alcon Research, Ltd.

FDA Devices Moderate Jul 6, 2016

Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract inc…

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, pres…

Nephron Pharmaceuticals Corp.

FDA Devices Moderate Jul 6, 2016

Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit inc…

Medtest Holdings, Inc.

FDA Devices Moderate Jul 6, 2016

Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestin…

Pentax Medical Company

FDA Devices Moderate Jul 6, 2016

Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid…

Medical Depot Inc.

FDA Devices Moderate Jul 6, 2016

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid a…

Smith & Nephew, Inc.

FDA Devices Moderate Jul 6, 2016

*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NO…

Hospira Inc.

FDA Devices Moderate Jul 6, 2016

*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP…

Hospira Inc.

CPSC Moderate Jul 6, 2016

Boscov's Recalls Self-Balancing Scooters/Hoverboards Due to Fire Hazard

Boscov's Department Store LLC, of Reading, Pa.

CPSC Moderate Jul 6, 2016

Digital Gadgets Recalls Self-Balancing Scooters/ Hoverboards Due to Fire Hazard

Digital Gadgets LLC, of Monroe, N.J.

CPSC Moderate Jul 6, 2016

Hoverboard LLC Recalls Self-Balancing Scooters/Hoverboards Due to Fire Hazard

Hoverboard LLC, of Scottsdale, Ariz.

CPSC Moderate Jul 6, 2016

Hype Wireless Recalls Self-Balancing Scooters/Hoverboards Due to Fire Hazard

Hype Wireless Ltd, of Edison, N.J.

CPSC Moderate Jul 6, 2016

Keenford Limited Recalls Self-Balancing Scooters/ Hoverboards Due to Fire Hazard

Keenford Limited, of Lynbrook, N.Y.

CPSC Moderate Jul 6, 2016

Little Lotus Baby Swaddles and Sleeping Bags Recalled by Embrace Technologies Due to Choking Hazard (Recall Alert)

Little Lotus, of San Francisco

CPSC Moderate Jul 6, 2016

Overstock.com Recalls Self-Balancing Scooters/Hoverboards Due to Fire Hazard

CPSC Moderate Jul 6, 2016

PTX Performance Products Recalls Self-Balancing Scooters/Hoverboards Due to Fire Hazard

PTX Performance Products USA, of Irvine, Calif.

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