PlainRecalls

2016 Recalls

8,148 recalls · Page 117 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 10 critical, 35 moderate, and 5 lower-severity recalls. The page references 33 distinct recalling firms operating in 6 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), FDA Drug (5), FDA Food (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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Food Moderate May 11, 2016

Salted Herring in pail, 30 pieces per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009

North Fish Usa

FDA Food Low May 11, 2016

Iowa Select Herbs LLC, Rhubarb Root (Rhizoma rhei), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402

Iowa Select Herbs LLC

FDA Food Moderate May 11, 2016

Assorted Dinner Rolls, 128 ct., Net Wt. 10.2 lbs; 16/ 8 ct./case

R.W. Bakers Co. Inc.

FDA Food Low May 11, 2016

Iowa Select Herbs LLC, Dandelion Leaf (Taraxacum officinale), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402

Iowa Select Herbs LLC

FDA Drug Moderate May 11, 2016

Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceB…

Akorn, Inc.

FDA Drug Low May 11, 2016

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, …

Bryant Ranch Prepack Inc.

FDA Drug Moderate May 11, 2016

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-…

VistaPharm, Inc.

FDA Drug Low May 11, 2016

Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively …

A-S Medication Solutions LLC.

FDA Drug Low May 11, 2016

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPI…

Hospira Inc.

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for impleme…

B Braun Medical Inc

FDA Devices Moderate May 11, 2016

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical syste…

Alcon Research, Ltd.

FDA Devices Moderate May 11, 2016

HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The …

Philips Electronics North America Corporation

FDA Devices Moderate May 11, 2016

TCM CombiM Modules 903-111

Radiometer America Inc

FDA Devices Moderate May 11, 2016

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

FDA Devices Moderate May 11, 2016

Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV Hig…

Biosense Webster, Inc.

FDA Devices Moderate May 11, 2016

MAKOplasty Hip Array Kit Laminate 150230

Mako Surgical Corporation

FDA Devices Moderate May 11, 2016

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate May 11, 2016

Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV…

Biosense Webster, Inc.

FDA Devices Moderate May 11, 2016

CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image…

Carestream Health Inc

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used fo…

B Braun Medical Inc

FDA Devices Moderate May 11, 2016

Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The versio…

Nuvectra

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatmen…

B Braun Medical Inc

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for im…

B Braun Medical Inc

FDA Devices Moderate May 11, 2016

MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 105…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 11, 2016

Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad …

Ferno-Washington Inc

FDA Devices Moderate May 11, 2016

Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, an…

Toshiba American Medical Systems Inc

FDA Devices Moderate May 11, 2016

Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a h…

Ferno-Washington Inc

FDA Devices Moderate May 11, 2016

Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B Car…

Medtronic Inc., Cardiac Rhythm and Heart Failure

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatm…

B Braun Medical Inc

FDA Devices Moderate May 11, 2016

Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200M…

Ab Sciex

FDA Devices Moderate May 11, 2016

Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resteril…

Applied Medical Technology Inc

FDA Devices Moderate May 11, 2016

ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 1043…

Siemens Medical Solutions USA, Inc.

FDA Devices Moderate May 11, 2016

TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retract…

Applied Medical Technology Inc

FDA Devices Critical May 11, 2016

Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and …

B Braun Medical Inc

FDA Devices Moderate May 11, 2016

Syngo Dynamics; Kinetdx Picture Archiving and Communications System

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 11, 2016

The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood g…

Livongo Health

FDA Devices Moderate May 11, 2016

VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an a…

Biomerieux Inc

FDA Devices Moderate May 11, 2016

Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

Applied Medical Technology Inc

FDA Devices Moderate May 11, 2016

GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications

GE Medical Systems, LLC

FDA Devices Moderate May 11, 2016

CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST…

Carestream Health Inc

FDA Devices Moderate May 11, 2016

Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

CareFusion 303, Inc.

FDA Devices Moderate May 11, 2016

TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retra…

Applied Medical Technology Inc

CPSC Moderate May 11, 2016

Robert Bosch Tool Recalls Grinders Due to Risk of Burns

Robert Bosch Tool Corp., of Mount Prospect, Ill.

CPSC Moderate May 11, 2016

TwinGo Recalls Baby Carriers Due to Fall Hazard

NHTSA Critical May 11, 2016

JEEP 2007-2010: AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE

JEEP

NHTSA Critical May 11, 2016

JEEP 2011-2016: AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE

JEEP

NHTSA Critical May 11, 2016

JEEP 2016: POWER TRAIN:AXLE ASSEMBLY:AXLE SHAFT

JEEP

NHTSA Critical May 11, 2016

JEEP 2016: POWER TRAIN:AXLE ASSEMBLY:AXLE SHAFT

JEEP

CPSC Moderate May 10, 2016

American Honda Recalls Recreational Off-Highway Vehicles Due to Risk of Injury (Recall Alert)

American Honda Motor Company Inc., of Torrance, Calif.

CPSC Moderate May 10, 2016

Bednest Recalls Bedside Infant Sleepers Due to Fall Hazard (Recall Alert)

Bednest Ltd., of UK

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