PlainRecalls

2016 Recalls

8,148 recalls · Page 121 of 163

2016 Recall Year Insight

Federal agencies issued 8,148 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 9.71% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 22.3 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 163 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 1 critical, 46 moderate, and 3 lower-severity recalls. The page references 24 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (41), FDA Drug (9), 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 Drug Moderate Apr 27, 2016

Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 03…

Hospira Inc.

FDA Drug Moderate Apr 27, 2016

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 0…

Hospira Inc.

FDA Drug Moderate Apr 27, 2016

Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 6…

Impax Laboratories, Inc.

FDA Drug Moderate Apr 27, 2016

Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030…

Hospira Inc.

FDA Drug Moderate Apr 27, 2016

Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64…

Impax Laboratories, Inc.

FDA Drug Moderate Apr 27, 2016

Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 03…

Hospira Inc.

FDA Drug Moderate Apr 27, 2016

Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14

Hospira Inc.

FDA Drug Moderate Apr 27, 2016

Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 41780…

Hospira Inc.

FDA Drug Low Apr 27, 2016

Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 …

Torrent Pharmaceuticals Limited

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product …

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to pr…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 27, 2016

GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embol…

Stryker Neurovascular

FDA Devices Critical Apr 27, 2016

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of f…

Boston Scientific Corporation

FDA Devices Moderate Apr 27, 2016

Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is cl…

Leica Microsystems, Inc.

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring tr…

Ossur H / F

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG Product …

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring tr…

Ossur H / F

FDA Devices Moderate Apr 27, 2016

The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.

Spacelabs Healthcare Inc

FDA Devices Moderate Apr 27, 2016

GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for emboliz…

Stryker Neurovascular

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG Produc…

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product …

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG Produc…

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Produ…

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product…

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

VariAx Compression Plating System

Stryker Howmedica Osteonics Corp.

FDA Devices Moderate Apr 27, 2016

Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm L…

Synthes (USA) Products LLC

FDA Devices Moderate Apr 27, 2016

MEVION S250 for Proton Radiation Therapy

Mevion Medical Systems, Inc.

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring …

Ossur H / F

FDA Devices Moderate Apr 27, 2016

iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a n…

Optovue, Inc.

FDA Devices Moderate Apr 27, 2016

ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hemat…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Apr 27, 2016

CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose…

Medtronic MiniMed Inc.

FDA Devices Low Apr 27, 2016

Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-P…

Biocare Medical, LLC

FDA Devices Moderate Apr 27, 2016

Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discus…

Coloplast Manufacturing US, LLC

FDA Devices Moderate Apr 27, 2016

Robotic Arm Interactive Orthopedic System (RIO)

Mako Surgical Corporation

FDA Devices Moderate Apr 27, 2016

Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Prod…

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Produ…

Smith & Nephew, Inc.

FDA Devices Low Apr 27, 2016

OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the li…

OraSure Technologies, Inc.

FDA Devices Moderate Apr 27, 2016

Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images o…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG Produ…

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

Acorn 180 Curved Stairlift

Acorn Stairlifts Inc

FDA Devices Moderate Apr 27, 2016

CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Em…

Abbott Laboratories

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product …

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring…

Ossur H / F

FDA Devices Moderate Apr 27, 2016

Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requirin…

Ossur H / F

FDA Devices Moderate Apr 27, 2016

Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Apr 27, 2016

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Produc…

Smith & Nephew, Inc.

FDA Devices Moderate Apr 27, 2016

Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connector…

Ad-Tech Medical Instrument Corporation

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