2015 Product Recalls (8,173)

2015 Recall Year Insight

Federal agencies issued 8,173 product recalls indexed by PlainRecalls in calendar year 2015. That represents about 7.83% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 22.4 recalls per day across the FDA, CPSC, USDA FSIS, 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 164 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 26 critical, 22 moderate, and 2 lower-severity recalls. The page references 27 distinct recalling firms operating in 6 distinct product categories, with 42 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Food (22), FDA Devices (16), 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

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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 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.

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 Manuals.

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 purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

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 intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structur

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 therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

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 ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.

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 (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.

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 endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

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 used to process tissue specimens for examination through fixation, dehydration and infiltration.

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 primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

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 breathing. Designed to be used in either a hospital or homecare environment.

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 used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.

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 edentulous patient.

Biomet 3i, LLC

CPSC No agency class Sep 23, 2015

Beet + Grapefruit Shrub Sorbet Pint Case, 205, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Beet + Grapefruit Shrub Ssorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.

Jeni's Splendid Ice Creams LLC

2015 Recall Year Insight

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

Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.

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

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 (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.

The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.

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

NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.

CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.

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

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

CleggPromo Recalls CPB-100 Power Banks Due to Fire Hazard

MITSUBISHI 2012-2014: AIR BAGS

RAM 2016: ENGINE AND ENGINE COOLING:ENGINE

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

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

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

MITSUBISHI 2011: EQUIPMENT:OTHER:LABELS

TOYOTA 2009-2014: VISIBILITY/WIPER

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

The Land of Nod Recalls Mobiles Due to Entanglement and Strangulation Hazards

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

FSIS Issues Public Health Alert For Stuffed Chicken Products Due To Possible Salmonella Contamination

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

Beet + Grapefruit Shrub Sorbet Pint Case, 205, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Beet + Grapefruit Shrub Ssorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.

Blackout Terrine Slice, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, individually packed, frozen. Blackout Terrine Slice Case, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, 12 slices per case, frozen.

Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.

Mini Chocolate Truffle Sandwich Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 7 sandwiches per sleeve, frozen.

IQF Red Tart Cherries, 30 lbs., 2/5 lb packages/case, 4/5 lb. packages per case; packed in cartons, square plastic pails, and poly bag in cartons; Nature Blessed Red Tart Cherries, 4/40 oz. packages per case.

Guava Buttermilk Frozen Yogurt Sandwich Case, 507, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, 14 boxes per case, frozen.

Bitter Lemon Ice Bucket, 816, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bitter Lemon Ice Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.

Hot Toddy Sorbet Pint Case, 202, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Hot Toddy Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.

Nearby Recall Years

Data Sources