PlainRecalls

2015 Recalls

Compiled from official public sources by the editorial team.

8,016 recalls · Page 43 of 161

2015 Recall Year Insight

Federal agencies issued 8,016 product recalls indexed by PlainRecalls in calendar year 2015. That represents about 7.88% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 22.0 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 161 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 2015.

On this page of 50 records, severity classification shows 7 critical, 40 moderate, and 3 lower-severity recalls. The page references 35 distinct recalling firms operating in 6 distinct product categories, with 43 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (26), FDA Drug (12), NHTSA (7), 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 2015 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.

← 2014 2016 →
FDA Drug Moderate Sep 23, 2015

Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of Am…

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxv…

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN

The Compounding Pharmacy of America
FDA Drug Moderate Sep 23, 2015

Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

The Compounding Pharmacy of America
FDA Devices Moderate Sep 23, 2015

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Us…

Intuitive Surgical, Inc.
FDA Devices Low Sep 23, 2015

Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE pla…

Pointe Scientific, Inc.
FDA Devices Moderate Sep 23, 2015

Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pres…

Edward Lifesciences, Llc
FDA Devices Moderate Sep 23, 2015

Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU…

Boston Scientific Corporation
FDA Devices Critical Sep 23, 2015

Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCar…

SynCardia Systems Inc.
FDA Devices Moderate Sep 23, 2015

Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Elec…

Applied Medical Resources Corp
FDA Devices Moderate Sep 23, 2015

XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cel…

Revmedx Inc
FDA Devices Moderate Sep 23, 2015

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminis…

Orthovita, Inc., dBA Stryker Orthobiologics.
FDA Devices Moderate Sep 23, 2015

Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emittin…

Sony Medical Systems
FDA Devices Moderate Sep 23, 2015

Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU200…

Boston Scientific Corporation
FDA Devices Low Sep 23, 2015

Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250…

Pointe Scientific, Inc.
FDA Devices Moderate Sep 23, 2015

Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manua…

Fujifilm Medical Systems U.S.A., Inc.
FDA Devices Moderate Sep 23, 2015

Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purpos…

Bayer Healthcare
FDA Devices Moderate Sep 23, 2015

ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is in…

Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Sep 23, 2015

Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation the…

RAYSEARCH LABORATORIES AB
FDA Devices Moderate Sep 23, 2015

Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ul…

Medivators, Inc.
FDA Devices Moderate Sep 23, 2015

Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.

St Jude Medical Cardiac Rhythm Management Division
FDA Devices Moderate Sep 23, 2015

MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (…

MedtestDx, Inc.
FDA Devices Moderate Sep 23, 2015

Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or end…

Lumenis
FDA Devices Low Sep 23, 2015

The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system …

Leica Microsystems, Inc.
FDA Devices Moderate Sep 23, 2015

CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

Advanced Sterilization Products
FDA Devices Moderate Sep 23, 2015

NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primar…

Nico Corp.
FDA Devices Moderate Sep 23, 2015

NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for brea…

Salter Labs
FDA Devices Moderate Sep 23, 2015

CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are …

Med Tec Inc
FDA Devices Moderate Sep 23, 2015

Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

Medtronic Inc. Cardiac Rhythm Disease Management
FDA Devices Moderate Sep 23, 2015

UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely…

Biomet 3i, LLC
CPSC Moderate Sep 23, 2015

CleggPromo Recalls CPB-100 Power Banks Due to Fire Hazard

Sinotec Technology, of Hong Kong, China
NHTSA Critical Sep 23, 2015

MITSUBISHI 2012-2014: AIR BAGS

MITSUBISHI
NHTSA Critical Sep 23, 2015

RAM 2016: ENGINE AND ENGINE COOLING:ENGINE

RAM
NHTSA Critical Sep 23, 2015

FIAT 2015: AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE

FIAT
NHTSA Critical Sep 22, 2015

SUZUKI 2012-2013: STEERING:HYDRAULIC POWER ASSIST:PUMP

SUZUKI
NHTSA Critical Sep 22, 2015

FREIGHTLINER 2015-2016: SERVICE BRAKES, AIR:DISC:CALIPER

FREIGHTLINER
NHTSA Moderate Sep 21, 2015

MITSUBISHI 2011: EQUIPMENT:OTHER:LABELS

MITSUBISHI
NHTSA Critical Sep 18, 2015

TOYOTA 2009-2014: VISIBILITY/WIPER

TOYOTA
CPSC Moderate Sep 17, 2015

Bed Handles Inc. Reannounces Recall of Adult Portable Bed Handles Due to Serious Entrapment and Strangulation Hazards

Bed Handles Inc., of Blue Springs, Mo.
CPSC Moderate Sep 17, 2015

The Land of Nod Recalls Mobiles Due to Entanglement and Strangulation Hazards
CPSC Moderate Sep 17, 2015

Zak Designs Recalls Water Bottles Due to Choking Hazard; Sold Exclusively at Target Stores

Zak Designs Inc., of Airway Heights, Wash.
FDA Food Moderate Sep 16, 2015

Red Tart Pitted Cherries, Straight Packed (No Sugar), 5 lbs. bulk pails, 30 lbs, in bulk pails

Coloma Frozen Foods, Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

2013 2014 2016 2017 2018

Compare 2015 with 2014 →

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 2015

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2015 across the FDA, CPSC 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 July 2026.