PlainRecalls

2015 Recalls

8,173 federal recalls indexed for 2015 · Page 7 of 164

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 9 critical, 41 moderate, and 0 lower-severity recalls. The page references 30 distinct recalling firms operating in 6 distinct product categories, with 44 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (33), CPSC (6), NHTSA (6), 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.

← 2014 2016 →
FDA Devices Moderate Dec 16, 2015

DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

Implant Direct Sybron Manufacturing, LLC
FDA Devices Moderate Dec 16, 2015

Thin-Flex Venous Cannula, Model Number:TF292902A

Edwards Lifesciences, LLC
FDA Devices Moderate Dec 16, 2015

The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

Powers Medical Devices, LLC
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate

Smith & Nephew, Inc.
FDA Devices Moderate Dec 16, 2015

Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

STERILMED, INC.
FDA Devices Moderate Dec 16, 2015

Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

Olympus Corporation of the Americas
FDA Devices Moderate Dec 16, 2015

IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

In2Bones, SAS
FDA Devices Moderate Dec 16, 2015

Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.

Zimmer, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. An additional intended u

Philips Medical Systems, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.

GE Medical Systems, LLC
FDA Devices Moderate Dec 16, 2015

Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Dec 16, 2015

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

BioHorizons Implant Systems Inc
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

AMS 4675 Angio Pack. For use in a general clinical procedure.

Windstone Medical Packaging, Inc.
FDA Devices Moderate Dec 16, 2015

Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.

Synthes (USA) Products LLC
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.

Zimmer, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
FDA Devices Moderate Dec 16, 2015

One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

Boston Scientific Corp
FDA Devices Moderate Dec 16, 2015

Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole

Valeant Pharmaceuticals North America LLC
FDA Devices Moderate Dec 16, 2015

The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital

Visicu, Inc.
FDA Devices Moderate Dec 16, 2015

AMS 4674 Custom Pack. For use in a general clinical procedure.

Windstone Medical Packaging, Inc.
FDA Devices Moderate Dec 16, 2015

LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.

LeMaitre Vascular, Inc.
CPSC No agency class Dec 16, 2015

Skip Hop Recalls Crib Mobiles Due to Injury Hazard
NHTSA No agency class Dec 16, 2015

ASTON MARTIN 2009-2015: LATCHES/LOCKS/LINKAGES

ASTON MARTIN
NHTSA No agency class Dec 16, 2015

MERCEDES-BENZ 2015: STEERING:ELECTRIC POWER ASSIST SYSTEM

MERCEDES-BENZ
NHTSA No agency class Dec 16, 2015

SUZUKI 2013: FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS

SUZUKI
CPSC No agency class Dec 15, 2015

Kawasaki Expands Recall of Teryx and Teryx4 Recreational Off-Highway Vehicles Due to Injury Hazard (Recall Alert)

Kawasaki Motors Corp., U.S.A., of Irvine, Calif.
CPSC No agency class Dec 15, 2015

Lithonia Lighting Recalls Light Fixtures Due to Risk of Injury (Recall Alert)
NHTSA No agency class Dec 11, 2015

BUICK,CHEVROLET,GMC 2016: SEATS

BUICK,CHEVROLET,GMC
CPSC No agency class Dec 10, 2015

Dollar Tree Recalls Burn Relief Gel Due to Failure to Meet Child Resistant Closure Requirement
CPSC No agency class Dec 10, 2015

Polaris Recalls RZR XP Turbo Recreational Off-Highway Vehicles Due to Fire Hazard (Recall Alert)

Polaris Industries Inc., of Medina, Minn.
CPSC No agency class Dec 10, 2015

Polaris Recalls Snowmobiles Due to Crash Hazard (Recall Alert)

Polaris Industries Inc., of Medina, Minn.
NHTSA No agency class Dec 10, 2015

FORD 2015: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:CALIPER

FORD
NHTSA No agency class Dec 10, 2015

CHEVROLET,GMC 2016: AIR BAGS:FRONTAL:SENSOR/CONTROL MODULE-INACTIVE

CHEVROLET,GMC
FDA Food Critical Dec 9, 2015

Kozy Shack Indulgent Salted Caramel

Land O' Lakes, Inc
FDA Food Critical Dec 9, 2015

Wegman's Italian Classics Pine Nuts, 3oz (85g), 6 cartons/case, UPC 0-77890-24823-2

World Variety Produce Inc.
FDA Food Moderate Dec 9, 2015

David's Gourmet Chocolate Chunk Pecan Cookie 10 count NET WT 15 oz (0.94 lb) packed in white cardboard box

Brookshire Brothers LTD-Central Bakery Plant
FDA Food Critical Dec 9, 2015

Melissa's Italian Pine Nuts, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5 Melissa's Profit Strip Pine Nuts Italy, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5.

World Variety Produce Inc.
FDA Food Critical Dec 9, 2015

DR. VENESSA'S FORMULAS ULTIMATE ANTIOXIDANT TABLETS DIETARY SUPPLEMENT, 120 count bottles, UPC 606851551205

VRVK Nutraceuticals, LLC

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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2015

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