PlainRecalls

2016 Recall Year Insight

Federal agencies issued 8,349 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.00% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 22.9 recalls per day across the FDA, CPSC, USDA FSIS, 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 167 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 4 critical, 45 moderate, and 1 lower-severity recalls. The page references 25 distinct recalling firms operating in 4 distinct product categories, with 48 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (39), CPSC (6), USDA FSIS (3), 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Moderate Aug 10, 2016

Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical Inc

FDA Devices Moderate Aug 10, 2016

Medtronic Navigation, Inc.

FDA Devices Moderate Aug 10, 2016

6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery o

AccessClosure, Inc., A Cardinal Health Company

FDA Devices Moderate Aug 10, 2016

91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

Spacelabs Healthcare Inc

FDA Devices Moderate Aug 10, 2016

Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.

Olympus Scientific Solutions Americas

FDA Devices Moderate Aug 10, 2016

RePlant¿ Angled Abutment Part Number 6050-52-60

Implant Direct Sybron Manufacturing, LLC

FDA Devices Moderate Aug 10, 2016

Medtronic Navigation, Inc.

FDA Devices Moderate Aug 10, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Merge Healthcare, Inc.

FDA Devices Moderate Aug 10, 2016

ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Aug 10, 2016

Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod,

Medtronic Navigation, Inc.

FDA Devices Moderate Aug 10, 2016

Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air De

Zimmer Surgical Inc

FDA Devices Moderate Aug 10, 2016

Merge HEMO software.

Merge Healthcare, Inc.

FDA Devices Moderate Aug 10, 2016

Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical Inc

FDA Devices Moderate Aug 10, 2016

Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical Inc

FDA Devices Moderate Aug 10, 2016

IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

Philips Electronics North America Corporation

FDA Devices Moderate Aug 10, 2016

AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

Beckman Coulter Inc.

FDA Devices Moderate Aug 10, 2016

Spirit Plus Bed, A-C Powered Hospital Bed

CHG Hospital Beds Inc

FDA Devices Moderate Aug 10, 2016

AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

Beckman Coulter Inc.

FDA Devices Moderate Aug 10, 2016

V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Zimmer Gmbh

FDA Devices Moderate Aug 10, 2016

MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

Philips Electronics North America Corporation

FDA Devices Moderate Aug 10, 2016

Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome

Zimmer Surgical Inc

FDA Devices Moderate Aug 10, 2016

Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical Inc

FDA Devices Moderate Aug 10, 2016

Dako Denmark A/S

FDA Devices Moderate Aug 10, 2016

Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

Mentor Texas, LP.

FDA Devices Moderate Aug 10, 2016

Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long b

Medtronic Navigation, Inc.

FDA Devices Moderate Aug 10, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Merge Healthcare, Inc.

FDA Devices Moderate Aug 10, 2016

Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

Zimmer Surgical Inc

FDA Devices Moderate Aug 10, 2016

TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Zimmer Gmbh

FDA Devices Moderate Aug 10, 2016

3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can

NeoCoil, LLC

FDA Devices Moderate Aug 10, 2016

Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or ver

Medtronic Navigation, Inc.

FDA Devices Moderate Aug 10, 2016

TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Zimmer Gmbh

FDA Devices Moderate Aug 10, 2016

UroDiagnost; x-ray system. Product Code: 708033

Philips Electronics North America Corporation

FDA Devices Moderate Aug 10, 2016

VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

ORTHO-CLINICAL DIAGNOSTICS

FDA Devices Low Aug 10, 2016

SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

C.R. Bard, Inc.

FDA Devices Moderate Aug 10, 2016

BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

B-K Medical A/S

FDA Devices Moderate Aug 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

CHG Hospital Beds Inc

FDA Devices Moderate Aug 10, 2016

MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long

Medtronic Navigation, Inc.

FDA Devices Moderate Aug 10, 2016

MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod,

Medtronic Navigation, Inc.

FDA Devices Moderate Aug 10, 2016

MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

Philips Electronics North America Corporation

CPSC No agency class Aug 10, 2016

Dennis East International Recalls Whiskey Glass and Stone Sets Due to Laceration Hazard

Dennis East International, LLC of Yarmouth Port, Mass.

CPSC No agency class Aug 10, 2016

Shocker Paintball Recalls Paintball Markers Due to Risk of Injury

Shocker Paintball, of Loyalhanna, Pa.

NHTSA No agency class Aug 10, 2016

JEEP 2014-2016: SEATS

JEEP

NHTSA No agency class Aug 10, 2016

CHRYSLER 2016: STEERING

CHRYSLER

USDA FSIS Critical Aug 10, 2016

Al Shabrawy Incorporated Recalls Meat and Poultry Products Due To Misbranding and Undeclared Allergens

Al Shabrawy Inc.

USDA FSIS Moderate Aug 10, 2016

Sam Kane Beef Processors, LLC Recalls Ground Beef Products Due To Possible Foreign Material Contamination

CPSC No agency class Aug 9, 2016

Brown Jordan Services Recalls Swivel Patio Chairs Due to Fall Hazard; Sold Exclusively at Home Depot

JiangSu Sunnyland Furniture Manufacturing Co. Ltd., of China

CPSC No agency class Aug 9, 2016

Flos Recalls Pendant Light Fixtures Due to Risk of Injury

CPSC No agency class Aug 9, 2016

Kohler Power Systems Recalls Portable Generators Due to Shock Hazard

Sumec Machinery & Electric Co. Ltd., of China

USDA FSIS Critical Aug 6, 2016

Al Shabrawy Meat Incorporated Recalls Meat and Poultry Products Due To Misbranding and Undeclared Allergens

Al Shabrawy Inc.

CPSC No agency class Aug 4, 2016

Cinmar Recalls World Magnetic Travel Maps Due To Risk of Magnet Ingestion by Children; Sold Exclusively at Frontgate (Recall Alert)

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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2016

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2016 across the FDA, CPSC, USDA FSIS 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 September 2026.