PlainRecalls

2016 Recalls

8,148 recalls · Page 140 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, 39 moderate, and 1 lower-severity recalls. The page references 27 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Low Mar 16, 2016

Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plasti…

Ecolab Inc

FDA Drug Moderate Mar 16, 2016

Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

Hartley Medical Center Pharmacy, Incorporated

FDA Drug Moderate Mar 16, 2016

Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

Hartley Medical Center Pharmacy, Incorporated

FDA Drug Moderate Mar 16, 2016

Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

Hartley Medical Center Pharmacy, Incorporated

FDA Devices Critical Mar 16, 2016

Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, wh…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Moderate Mar 16, 2016

VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro…

Ortho-Clinical Diagnostics

FDA Devices Critical Mar 16, 2016

MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 0871764…

Abbott Vascular

FDA Devices Moderate Mar 16, 2016

Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed …

GE Medical Systems, LLC

FDA Devices Moderate Mar 16, 2016

M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

Zimmer Biomet, Inc.

FDA Devices Moderate Mar 16, 2016

Milex Arcing Diaphragm Size 95; Model Number: MXWS95

CooperSurgical, Inc.

FDA Devices Moderate Mar 16, 2016

Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyve…

Gi Supply

FDA Devices Critical Mar 16, 2016

Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereb…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Moderate Mar 16, 2016

LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole…

GE Medical Systems, LLC

FDA Devices Moderate Mar 16, 2016

LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X…

GE Medical Systems, LLC

FDA Devices Moderate Mar 16, 2016

VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbish…

Ortho-Clinical Diagnostics

FDA Devices Moderate Mar 16, 2016

Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular…

Philips Electronics North America Corporation

FDA Devices Moderate Mar 16, 2016

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

ConforMIS, Inc.

FDA Devices Moderate Mar 16, 2016

Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed …

GE Medical Systems, LLC

FDA Devices Critical Mar 16, 2016

Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereb…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Moderate Mar 16, 2016

LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray …

GE Medical Systems, LLC

FDA Devices Moderate Mar 16, 2016

VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic …

Ortho-Clinical Diagnostics

FDA Devices Critical Mar 16, 2016

RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereb…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Critical Mar 16, 2016

UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, wh…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Critical Mar 16, 2016

FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflat…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Moderate Mar 16, 2016

BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and …

Verathon, Inc.

FDA Devices Moderate Mar 16, 2016

TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment

Ormco/Sybronendo

FDA Devices Moderate Mar 16, 2016

Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71…

Value Plastics, Inc.

FDA Devices Moderate Mar 16, 2016

Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placemen…

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 16, 2016

Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross …

Biomet, Inc.

FDA Devices Moderate Mar 16, 2016

VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Devic…

Ortho-Clinical Diagnostics

FDA Devices Moderate Mar 16, 2016

LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Com…

GE Medical Systems, LLC

FDA Devices Moderate Mar 16, 2016

Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism v…

Bard Peripheral Vascular Inc

FDA Devices Moderate Mar 16, 2016

VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic…

Ortho-Clinical Diagnostics

FDA Devices Moderate Mar 16, 2016

IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. I…

CMP Industries, Llc

FDA Devices Moderate Mar 16, 2016

Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continu…

Philips Respironics

FDA Devices Moderate Mar 16, 2016

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro…

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Mar 16, 2016

Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric p…

Sedecal S.A.

FDA Devices Critical Mar 16, 2016

UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, wh…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Critical Mar 16, 2016

Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whe…

Arrow International, Inc., Division of Teleflex Medical Inc.

FDA Devices Critical Mar 16, 2016

GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-pa…

Verathon, Inc.

FDA Devices Moderate Mar 16, 2016

iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7…

Beckman Coulter Inc.

FDA Devices Moderate Mar 16, 2016

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For in vi…

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Mar 16, 2016

Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients con…

Spacelabs Healthcare Inc

FDA Devices Moderate Mar 16, 2016

Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibrator E…

Siemens Healthcare Diagnostics, Inc

FDA Devices Moderate Mar 16, 2016

Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for u…

Biomet, Inc.

FDA Devices Moderate Mar 16, 2016

Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low …

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate Mar 16, 2016

Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic an…

Medtronic Navigation, Inc.

FDA Devices Moderate Mar 16, 2016

BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center set…

Becton Dickinson & Company

FDA Devices Moderate Mar 16, 2016

Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Intro…

Arrow International Inc

FDA Devices Moderate Mar 16, 2016

ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and p…

TEM Systems 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