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 10 critical, 35 moderate, and 5 lower-severity recalls. The page references 24 distinct recalling firms operating in 5 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (23), FDA Food (16), FDA Drug (11), 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 Food Critical Aug 31, 2016

OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.

SM Fish Corp.

FDA Food Moderate Aug 31, 2016

La Torre Foods Usa, Inc.

FDA Food Moderate Aug 31, 2016

Columbia River Chinook Salmon -Custom Smoked, NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Moderate Aug 31, 2016

Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks Net Wt .5 oz (14g) Distributed by Mondelez Global LL East Hanover, NJ 07936 USA UPC 019320016769

Mondelez International

FDA Food Moderate Aug 31, 2016

Wild Columbia River Sturgeon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Critical Aug 31, 2016

OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.

SM Fish Corp.

FDA Food Critical Aug 31, 2016

OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.

SM Fish Corp.

FDA Food Moderate Aug 31, 2016

The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial Flavored, Net WT 5.0 OZ (142 g), UPC 7 63913 13003 4.

Northern Tier Bakery (dba\ Super Mom's)

FDA Food Moderate Aug 31, 2016

Oregon Sardines - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Moderate Aug 31, 2016

Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Moderate Aug 31, 2016

Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Critical Aug 31, 2016

OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.

SM Fish Corp.

FDA Food Critical Aug 31, 2016

OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114174; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.

SM Fish Corp.

FDA Food Critical Aug 31, 2016

OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.

SM Fish Corp.

FDA Food Moderate Aug 31, 2016

Oregon Sardines - Spicy Tomato-NW Wild Products, 6.5 oz. metal cans. No UPC

Northwest Wild Products

FDA Food Critical Aug 31, 2016

OSSIE'S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.

SM Fish Corp.

FDA Drug Low Aug 31, 2016

Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY

Exact-Rx Inc

FDA Drug Moderate Aug 31, 2016

Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247

Talon Compounding Pharmacy

FDA Drug Low Aug 31, 2016

Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82

Actavis Inc

FDA Drug Moderate Aug 31, 2016

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Drug Moderate Aug 31, 2016

Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247

Talon Compounding Pharmacy

FDA Drug Moderate Aug 31, 2016

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

Teva North America

FDA Drug Low Aug 31, 2016

Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61

Actavis Inc

FDA Drug Low Aug 31, 2016

Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.

Stratus Pharmaceuticals Inc

FDA Drug Moderate Aug 31, 2016

Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Drug Low Aug 31, 2016

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

Akorn, Inc.

FDA Drug Moderate Aug 31, 2016

Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Aug 31, 2016

Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to th

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

Vision RT Ltd

FDA Devices Moderate Aug 31, 2016

Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

Cook Inc.

FDA Devices Moderate Aug 31, 2016

NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The

Novarad Corporation

FDA Devices Critical Aug 31, 2016

Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging

Ziehm Imaging Inc

FDA Devices Moderate Aug 31, 2016

120 V Neptune 3 Rover, Model Number: 0703-001-000

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Aug 31, 2016

SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 31, 2016

Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland) Inc

FDA Devices Critical Aug 31, 2016

Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the dis

Alere San Diego, Inc.

FDA Devices Moderate Aug 31, 2016

BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

Bovie Medical Corporation

FDA Devices Moderate Aug 31, 2016

RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Aug 31, 2016

Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Aug 31, 2016

Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.

Conmed Corporation

FDA Devices Moderate Aug 31, 2016

Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.

Integra LifeSciences Corp.

FDA Devices Moderate Aug 31, 2016

Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

Cook Inc.

FDA Devices Moderate Aug 31, 2016

Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques

Cook Inc.

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.