PlainRecalls

2016 Recalls

6,806 recalls · Page 50 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 5 critical, 42 moderate, and 3 lower-severity recalls. The page references 28 distinct recalling firms operating in 2 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), FDA Drug (17), 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 Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single …

Amerisource Health Services

FDA Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity A…

Amerisource Health Services

FDA Drug Moderate Sep 14, 2016

Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (ND…

Allergy Laboratories, Inc.

FDA Drug Moderate Sep 14, 2016

Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Si…

Teva North America

FDA Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity A…

Amerisource Health Services

FDA Drug Low Sep 14, 2016

Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas P…

Stason Pharmaceuticals, Inc.

FDA Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity A…

Amerisource Health Services

FDA Drug Moderate Sep 14, 2016

Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS…

Teva North America

FDA Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity A…

Amerisource Health Services

FDA Drug Moderate Sep 14, 2016

Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 07…

Teva North America

FDA Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single …

Amerisource Health Services

FDA Drug Moderate Sep 14, 2016

Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus…

Zydus Pharmaceuticals USA Inc

FDA Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single …

Amerisource Health Services

FDA Drug Low Sep 14, 2016

Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactu…

Lupin Limited

FDA Drug Moderate Sep 14, 2016

Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions,…

Isomeric Pharmacy Solution, LLC

FDA Drug Moderate Sep 14, 2016

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single …

Amerisource Health Services

FDA Drug Low Sep 14, 2016

Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufact…

Lupin Limited

FDA Devices Moderate Sep 14, 2016

ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Sep 14, 2016

Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of mult…

Hospira Inc.

FDA Devices Moderate Sep 14, 2016

Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise deliv…

Hospira Inc.

FDA Devices Moderate Sep 14, 2016

Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multi…

Hospira Inc.

FDA Devices Moderate Sep 14, 2016

Medical Linear Accelerator

Elekta, Inc.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FE…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - E…

Aribex Inc

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

Merge RadSuite software. Radiological image processing system.

Merge Healthcare, Inc.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Intro…

Terumo Medical Corporation

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FE…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding…

Advanced Medical Solutions Ltd.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.

Omega Medical Imaging, Inc.

FDA Devices Moderate Sep 14, 2016

NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray S…

Aribex Inc

FDA Devices Moderate Sep 14, 2016

SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12…

Hologic, Inc

FDA Devices Moderate Sep 14, 2016

Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL …

Riverpoint Medical, LLC

FDA Devices Moderate Sep 14, 2016

The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room ta…

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Sep 14, 2016

Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provi…

Hospira Inc.

FDA Devices Moderate Sep 14, 2016

SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20…

Hologic, Inc

FDA Devices Moderate Sep 14, 2016

Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended …

Arrow International Inc

FDA Devices Moderate Sep 14, 2016

Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are …

Zimmer Biomet, Inc.

FDA Devices Moderate Sep 14, 2016

Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.

Arrow International Inc

FDA Devices Moderate Sep 14, 2016

BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Sep 14, 2016

Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that prov…

Hospira Inc.

FDA Devices Moderate Sep 14, 2016

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, mo…

Ge Healthcare It

FDA Devices Moderate Sep 14, 2016

ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

FDA Devices Moderate Sep 14, 2016

MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast rec…

Mentor Texas, LP.

FDA Devices Moderate Sep 14, 2016

Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodyn…

Innovision A/S

FDA Devices Moderate Sep 14, 2016

BrightView XCT Upgrade Model 882454

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Sep 14, 2016

Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboar…

Hill-Rom, Inc.

FDA Devices Moderate Sep 14, 2016

Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for s…

Anthogyr

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