PlainRecalls

2016 Recalls

6,806 recalls · Page 105 of 137

2016 Recall Year Insight

Federal agencies issued 6,806 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.11% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 18.6 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 137 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 3 critical, 37 moderate, and 10 lower-severity recalls. The page references 20 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (38), FDA Drug (7), FDA Food (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 Apr 20, 2016

Puredesi Low Fat Yogurt in 2 lb. plastic containers Puredesi Low Fat Yogurt in 5 lb. plastic containers Puredahi Low Fat Yogurt in 2 lb. plastic co…

JRZ Dairy Products Inc.

FDA Food Moderate Apr 20, 2016

Blue Ridge Farms Krab Salad;09328; Net Weight 1 X 10 lb.; Keep Refrigerated; Use By: 03/15/16, 03/17/16; Lot #436, 438; Packed by Winter Gardens Qu…

Winter Gardens Quality Foods, Inc.

FDA Food Low Apr 20, 2016

Pioneer Brand No Fat Complete Buttermilk Pancake & Waffle Mix Premium Quality NET WT 32 oz. (2 lb) 907g packed in paper box

C. H. Guenther & Son, Inc.dba Morrison Milling

FDA Food Low Apr 20, 2016

Marie Callender's Low Fat Honey Butter Corn Bread and Muffin Mix NET WT 1 lb (16 oz. ) 454 grams

C. H. Guenther & Son, Inc.dba Morrison Milling

FDA Food Low Apr 20, 2016

Darden Super Breader XL NET WEIGHT 25 LB (11.34 kg)

C. H. Guenther & Son, Inc.dba Morrison Milling

FDA Drug Low Apr 20, 2016

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02

Impax Laboratories, Inc.

FDA Drug Moderate Apr 20, 2016

Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LL…

Fresenius Kabi USA, LLC

FDA Drug Low Apr 20, 2016

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dor…

Biocon Inc

FDA Drug Low Apr 20, 2016

Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Healt…

Amerisource Health Services

FDA Drug Low Apr 20, 2016

Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packag…

Amerisource Health Services

FDA Drug Low Apr 20, 2016

Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02

Impax Laboratories, Inc.

FDA Drug Low Apr 20, 2016

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Fresenius Kabi USA, LLC

FDA Devices Moderate Apr 20, 2016

Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray tran…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…

Customed, Inc

FDA Devices Critical Apr 20, 2016

Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patte…

Dexcom Inc

FDA Devices Moderate Apr 20, 2016

VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance techn…

Alcon Research, Ltd.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient car…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as w…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as woun…

Customed, Inc

FDA Devices Critical Apr 20, 2016

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (ped…

Dexcom Inc

FDA Devices Moderate Apr 20, 2016

Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

Neurotherm, Inc.

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an int…

Merit Medical Systems, Inc.

FDA Devices Moderate Apr 20, 2016

Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UP…

Boston Scientific Corporation

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound h…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator

Maquet Cardiovascular Us Sales, Llc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmiss…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 20, 2016

EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound im…

Philips Ultrasound, Inc.

FDA Devices Moderate Apr 20, 2016

Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmis…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutti…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedure…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such …

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray tra…

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound …

Customed, Inc

FDA Devices Moderate Apr 20, 2016

SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Du…

Synthes (USA) Products LLC

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures …

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over…

Arthrex, Inc.

FDA Devices Moderate Apr 20, 2016

SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCoun…

Stryker Instruments Div. of Stryker Corporation

FDA Devices Moderate Apr 20, 2016

Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, …

Customed, Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedur…

Customed, Inc

FDA Devices Low Apr 20, 2016

Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WAT…

Cygnus Medical

FDA Devices Critical Apr 20, 2016

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL…

Dexcom Inc

FDA Devices Moderate Apr 20, 2016

Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound…

Customed, 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: CPSC + NHTSA — consumer product and vehicle recall feeds for 2016