PlainRecalls

2016 Recalls

8,211 recalls · Page 60 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 8 critical, 42 moderate, and 0 lower-severity recalls. The page references 31 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

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

FDA Devices Moderate Sep 14, 2016

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Interne…

Invivo Corporation

FDA Devices Moderate Sep 14, 2016

Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liqui…

Best Sanitizers Inc

FDA Devices Moderate Sep 14, 2016

Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of mult…

Hospira Inc.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND

Integra LifeSciences Corp. d.b.a. Integra Pain Management

FDA Devices Moderate Sep 14, 2016

UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis …

Beckman Coulter Inc.

FDA Devices Moderate Sep 14, 2016

e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the fol…

Siemens Medical Solutions USA, Inc.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stella…

Bayer Healthcare

FDA Devices Moderate Sep 14, 2016

Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue …

Riverpoint Medical, LLC

FDA Devices Moderate Sep 14, 2016

Plum A+ Infusion Pump. List Number 11973. 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

Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the …

Sorin Group USA, Inc.

FDA Devices Moderate Sep 14, 2016

MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast rec…

Mentor Texas, LP.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FE…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery …

Hospira Inc.

FDA Devices Moderate Sep 14, 2016

Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to …

NOVADAQ TECHNOLOGIES INC.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FE…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Produ…

Teleflex Medical

FDA Devices Moderate Sep 14, 2016

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

Anthogyr

FDA Devices Moderate Sep 14, 2016

Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopot…

Blackrock Microsystems, LLC

FDA Devices Moderate Sep 14, 2016

Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System…

Blackrock Microsystems, LLC

FDA Devices Moderate Sep 14, 2016

Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." …

Aspen Surgical Puerto Rico Corp.

FDA Devices Critical Sep 14, 2016

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6…

MicroPort Orthopedics Inc.

FDA Devices Moderate Sep 14, 2016

Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provi…

Hospira Inc.

FDA Devices Moderate Sep 14, 2016

Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycard…

Boston Scientific 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

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.