2016 Recalls
8,349 federal recalls indexed for 2016 · Page 47 of 167
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 1 critical, 45 moderate, and 4 lower-severity recalls. The page references 23 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (46), FDA Drug (4), 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.
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Teva North America
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Biocompatibles U.K., Ltd.
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86
Sun Pharmaceutical Industries, Inc.
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
The Apothecary Shoppe LLC
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Trumpf Medical Systems, Inc.
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Trumpf Medical Systems, Inc.
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.
Siemens Medical Solutions USA, Inc
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
New Star Lasers, Inc.
Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Trumpf Medical Systems, Inc.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage
Integra LifeSciences Corp.
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Toshiba American Medical Systems Inc
Arthrex Suture Washer
Arthrex, Inc.
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
Integra LifeSciences Corp.
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuroma
New Star Lasers, Inc.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Merit Medical Systems, Inc.
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Arrow International Inc
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Trumpf Medical Systems, Inc.
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Philips Medical Systems
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Panoramic Rental Corp.
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Baxter Corporation Englewood
ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
LDR Spine USA, Inc.
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Argon Medical Devices, Inc
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Siemens Healthcare Diagnostics, Inc.
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Toshiba American Medical Systems Inc
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Vanguard 360 Revision Knee System Knee prostheses
Zimmer Biomet, Inc.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS E
Microgenics Corporation
TriFoillmaging Triumph/Triumph II Research CT scanners.
Northridge Tri-Modality Imaging,
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Integra LifeSciences Corp.
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Toshiba American Medical Systems Inc
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
Integra LifeSciences Corp.
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Ivoclar Vivadent, Inc.
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific. An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material
Cardinal Health
Nearby Recall Years
Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.
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.