PlainRecalls

2016 Recalls

8,148 recalls · Page 161 of 163

2016 Recall Year Insight

Federal agencies issued 8,148 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 9.71% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 22.3 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 163 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 9 critical, 38 moderate, and 3 lower-severity recalls. The page references 28 distinct recalling firms operating in 4 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (35), FDA Food (10), FDA Drug (5), 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 Food Moderate Jan 13, 2016

Nicomex Velitas Candies Candles Net. Wt. 2 oz (56.7 gms) Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055

Nicomex Inc.

FDA Food Critical Jan 13, 2016

Crazy about Cookies 2.7lb WALNUT CHUNKY CHOCOLATE CHIP Pre-Portioned cookie dough Item # 25-2008 UPC Code - 698768102168

Pine Valley Foods Inc

FDA Food Critical Jan 13, 2016

Crazy about Cookies 2lb HELLO KITTY COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4035 UPC Code - 698768034353

Pine Valley Foods Inc

FDA Food Moderate Jan 13, 2016

Made In Nature Sriracha Chili Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case

Made In Nature, LLC

FDA Food Critical Jan 13, 2016

Casey's Bakery, 8X8 Snickers cake, www.caseysbakery.com, Sioux Center, IA

Casey's Bakery, Inc

FDA Food Critical Jan 13, 2016

Crazy about Cookies 2.7lb Sugar Cookies Pre-Portion Item # 25-2004 UPC Code - 698768102120

Pine Valley Foods Inc

FDA Food Critical Jan 13, 2016

Crazy about Cookies 2lb Birthday Celebration COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4033 UPC Code - 698768034339

Pine Valley Foods Inc

FDA Food Critical Jan 13, 2016

Crazy about Cookies 2lb Monster Bash COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4032 UPC Code - 698768034322

Pine Valley Foods Inc

FDA Food Critical Jan 13, 2016

Crazy about Cookies 2lb Holiday Gathering COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4034 UPC Code - 698768034346

Pine Valley Foods Inc

FDA Food Critical Jan 13, 2016

Crazy about Cookies 2lb Fairytale Princess COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4031 UPC Code - 698768034315

Pine Valley Foods Inc

FDA Drug Low Jan 13, 2016

5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz…

Freedom Pharmaceuticals Inc

FDA Drug Moderate Jan 13, 2016

Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, O…

PD-Rx Pharmaceuticals, Inc.

FDA Drug Low Jan 13, 2016

Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Va…

Avantor Performance Materials Inc

FDA Drug Moderate Jan 13, 2016

Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc…

PD-Rx Pharmaceuticals, Inc.

FDA Drug Low Jan 13, 2016

EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylva…

PQ Corporation

FDA Devices Moderate Jan 13, 2016

NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stem…

Zimmer Manufacturing B.V.

FDA Devices Moderate Jan 13, 2016

Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a th…

Ethicon, Inc.

FDA Devices Moderate Jan 13, 2016

3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.

3M Company - Health Care Business

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Cata…

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jan 13, 2016

CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint foll…

Corflex

FDA Devices Moderate Jan 13, 2016

InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid fo…

Ultradent Products, Inc.

FDA Devices Moderate Jan 13, 2016

Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.

Otto Bock Healthcare GmbH

FDA Devices Moderate Jan 13, 2016

BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control at the knee…

Corflex

FDA Devices Moderate Jan 13, 2016

Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjuncti…

Vidco, Inc.

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: C…

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jan 13, 2016

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx…

Smith & Nephew, Inc.

FDA Devices Moderate Jan 13, 2016

Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint f…

Corflex

FDA Devices Moderate Jan 13, 2016

ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the knee joint…

Corflex

FDA Devices Moderate Jan 13, 2016

CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at the knee joi…

Corflex

FDA Devices Moderate Jan 13, 2016

BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an…

Biomet 3i, LLC

FDA Devices Moderate Jan 13, 2016

SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

Synthes (USA) Products LLC

FDA Devices Critical Jan 13, 2016

The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle,…

Stryker Sustainability Solutions

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jan 13, 2016

Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroence…

Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

FDA Devices Moderate Jan 13, 2016

Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For the admi…

Baxter Healthcare Corp.

FDA Devices Moderate Jan 13, 2016

AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solut…

Steris Corporation

FDA Devices Moderate Jan 13, 2016

MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, M…

Benlan, Inc.

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO S…

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jan 13, 2016

BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessor…

Biomet 3i, LLC

FDA Devices Moderate Jan 13, 2016

Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116…

Boston Scientific Corporation

FDA Devices Moderate Jan 13, 2016

ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings…

KCI USA, INC.

FDA Devices Moderate Jan 13, 2016

Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a…

Baxter Healthcare Corp.

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in …

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jan 13, 2016

CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized …

Partners In Medicine Llc

FDA Devices Moderate Jan 13, 2016

Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulat…

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Jan 13, 2016

Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vasc…

Baxter Healthcare Corp.

FDA Devices Moderate Jan 13, 2016

Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog…

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jan 13, 2016

HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicated for range of motion control at the knee joint …

Corflex

FDA Devices Moderate Jan 13, 2016

ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee …

Corflex

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