PlainRecalls

2016 Recalls

Compiled from official public sources by the editorial team.

8,211 recalls · Page 6 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 6 critical, 40 moderate, and 4 lower-severity recalls. The page references 28 distinct recalling firms operating in 3 distinct product categories, with 43 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (41), NHTSA (7), CPSC (2), 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 Dec 28, 2016

Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Case…

Stanmore Implants Worldwide Ltd.

FDA Devices Moderate Dec 28, 2016

OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connec…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of cath…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E19329…

Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

FDA Devices Low Dec 28, 2016

OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

OrthoPediatrics Corp

FDA Devices Low Dec 28, 2016

ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire…

Angiodynamics, Inc.

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly c…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component d…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic compon…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyn…

Teleflex Medical

FDA Devices Moderate Dec 28, 2016

Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distentio…

Northgate Technologies, Inc.

FDA Devices Moderate Dec 28, 2016

IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambe…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart cham…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly co…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connec…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart cham…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an a…

Teleflex Medical

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component direct…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

Exactech, Inc.

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chamber…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.

Merge Healthcare, Inc.

FDA Devices Low Dec 28, 2016

VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP S…

Ortho-Clinical Diagnostics

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chamb…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are d…

Amendia, Inc

FDA Devices Moderate Dec 28, 2016

ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the …

Medtronic Inc

FDA Devices Moderate Dec 28, 2016

Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVC…

Smiths Medical ASD Inc.

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart ch…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiome…

Radiometer America Inc

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers…

Oscor, Inc.

FDA Devices Low Dec 28, 2016

EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA…

PerkinElmer Health Sciences, Inc.

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chamb…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the…

Biomet 3i, LLC

FDA Devices Moderate Dec 28, 2016

OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chamber…

Oscor, Inc.

FDA Devices Moderate Dec 28, 2016

AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

FDA Devices Moderate Dec 28, 2016

8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove …

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Dec 28, 2016

8450-009-040 4.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseo…

Stryker Instruments Div. of Stryker Corporation

CPSC Moderate Dec 28, 2016

Suzuki Recalls KingQuad ATVs Due to Crash Hazard (Recall Alert)

Suzuki Manufacturing of America Corporation, of Rome, Ga.

CPSC Moderate Dec 28, 2016

Tea Collection Recalls Children's Denim Jackets Due to Choking Hazard

Tea Living Inc., d/b/a Tea Collection Inc. of San Francisco, Calif.

NHTSA Critical Dec 28, 2016

RAM 2017: AIR BAGS:SIDE/WINDOW

RAM

NHTSA Critical Dec 28, 2016

JAGUAR 2017: SEAT BELTS:PRETENSIONER

JAGUAR

NHTSA Critical Dec 28, 2016

INFINITI 2017: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

INFINITI

NHTSA Critical Dec 28, 2016

INTERNATIONAL 2017: ELECTRICAL SYSTEM:12V/24V/48V BATTERY

INTERNATIONAL

NHTSA Critical Dec 28, 2016

LEXUS,TOYOTA 2016-2017: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

LEXUS,TOYOTA

NHTSA Critical Dec 28, 2016

MASERATI 2017: ELECTRICAL SYSTEM:SOFTWARE

MASERATI

NHTSA Moderate Dec 27, 2016

MERCEDES-BENZ 2017: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

MERCEDES-BENZ

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.