PlainRecalls

2016 Recalls

Compiled from official public sources by the editorial team.

8,211 recalls · Page 17 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 0 critical, 43 moderate, and 7 lower-severity recalls. The page references 29 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 (37), FDA Drug (12), FDA Food (1), 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 Food Moderate Nov 30, 2016

7-Eleven Variety Cookie Base, 50#

CSM Bakery Products NA

FDA Drug Moderate Nov 30, 2016

Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Compan…

Akorn Inc

FDA Drug Low Nov 30, 2016

AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis El…

Amerisource Health Services

FDA Drug Moderate Nov 30, 2016

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

West-Ward Pharmaceuticals Corp.

FDA Drug Low Nov 30, 2016

Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., L…

Sandoz Inc

FDA Drug Low Nov 30, 2016

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured …

Mylan Pharmaceuticals Inc.

FDA Drug Low Nov 30, 2016

KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RAN…

Sun Pharmaceutical Industries, Inc.

FDA Drug Moderate Nov 30, 2016

Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx o…

VistaPharm, Inc.

FDA Drug Moderate Nov 30, 2016

Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

Hospira Inc.

FDA Drug Low Nov 30, 2016

Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amma…

West-Ward Pharmaceuticals Corp.

FDA Drug Low Nov 30, 2016

NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 0…

Actavis Elizabeth LLC

FDA Drug Low Nov 30, 2016

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, In…

Zydus Pharmaceuticals USA Inc

FDA Drug Moderate Nov 30, 2016

LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Br…

Pfizer Inc.

FDA Devices Moderate Nov 30, 2016

Extraction Hook - Sterile for TI Cannulated Nails

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introduce…

Greatbatch Medical

FDA Devices Moderate Nov 30, 2016

3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Pl…

DePuy Spine, Inc.

FDA Devices Moderate Nov 30, 2016

Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G

Merit Medical Systems, Inc.

FDA Devices Moderate Nov 30, 2016

3.0 mm Reaming Rod/950 mm, Sterile

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing…

Merge Healthcare, Inc.

FDA Devices Moderate Nov 30, 2016

Philips Healthcare System X-ray Tomography Computed :

Philips Electronics North America Corporation

FDA Devices Moderate Nov 30, 2016

2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Ch…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 30, 2016

Pathfast D-Dimer, Reference number: PF1051-KUS

Lsi Medience Corporation

FDA Devices Moderate Nov 30, 2016

COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700…

AtriCure, Inc.

FDA Devices Moderate Nov 30, 2016

Manifold Kit. Catalog Number K09-11867AP

Merit Medical Systems, Inc.

FDA Devices Moderate Nov 30, 2016

AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit…

Beckman Coulter Inc.

FDA Devices Moderate Nov 30, 2016

LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the …

Diasorin Inc.

FDA Devices Moderate Nov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical …

DePuy Spine, Inc.

FDA Devices Moderate Nov 30, 2016

Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedulla…

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy…

Pentax of America Inc

FDA Devices Moderate Nov 30, 2016

Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A

Merit Medical Systems, Inc.

FDA Devices Moderate Nov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervical Pla…

DePuy Spine, Inc.

FDA Devices Moderate Nov 30, 2016

2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

Waste Management Kit. Catalog Number K10-04381AP

Merit Medical Systems, Inc.

FDA Devices Moderate Nov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cervical…

DePuy Spine, Inc.

FDA Devices Moderate Nov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical P…

DePuy Spine, Inc.

FDA Devices Moderate Nov 30, 2016

The Hemotherm 400CE 115v, containing power board p/n 39945

Cincinnati Sub-Zero Products Inc

FDA Devices Moderate Nov 30, 2016

Philips Healthcare System X-ray Tomography Computed :

Philips Electronics North America Corporation

FDA Devices Moderate Nov 30, 2016

SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devi…

Hologic, Inc

FDA Devices Moderate Nov 30, 2016

PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. S…

Bausch & Lomb Inc Irb

FDA Devices Moderate Nov 30, 2016

Fluid Management Set. Catalog Number K08-MP5159A

Merit Medical Systems, Inc.

FDA Devices Moderate Nov 30, 2016

Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition …

Toshiba American Medical Systems Inc

FDA Devices Moderate Nov 30, 2016

2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE¿ Anterior Cervical Plate…

DePuy Spine, Inc.

FDA Devices Moderate Nov 30, 2016

3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

Synthes (USA) Products LLC

FDA Devices Moderate Nov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervical …

DePuy Spine, Inc.

FDA Devices Moderate Nov 30, 2016

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

Merit Medical Systems, Inc.

FDA Devices Moderate Nov 30, 2016

ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube …

Depuy Orthopaedics 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.