PlainRecalls

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 4 critical, 18 moderate, and 28 lower-severity recalls. The page references 20 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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.

FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 5 Panel Dip Card, Item No. PSD-12BUP

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

Terumo Medical Corp

FDA Devices Moderate Dec 30, 2015

Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

CareFusion 303, Inc.

FDA Devices Moderate Dec 30, 2015

Ingenuity Core 128 Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Low Dec 30, 2015

ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M

Ameditech Inc

FDA Devices Low Dec 30, 2015

DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.

Siemens Healthcare Diagnostics Inc.

FDA Devices Low Dec 30, 2015

ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

Synaptive Medical, Inc.

FDA Devices Critical Dec 30, 2015

Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.

Draeger Medical, Inc.

FDA Devices Low Dec 30, 2015

THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5

Ameditech Inc

FDA Devices Low Dec 30, 2015

Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU

Ameditech Inc

FDA Devices Critical Dec 30, 2015

Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

Biomerieux

FDA Devices Low Dec 30, 2015

DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double

Cardica, Inc.

FDA Devices Moderate Dec 30, 2015

Green Mamba Suture Passer

Biomet, Inc.

FDA Devices Moderate Dec 30, 2015

Ingenuity Core Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc

FDA Devices Moderate Dec 30, 2015

FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.

Hardy Diagnostics

FDA Devices Low Dec 30, 2015

iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142

Ameditech Inc

FDA Devices Low Dec 30, 2015

12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, dru

Boston Scientific Corp

FDA Devices Moderate Dec 30, 2015

Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

Airways Development LLC

FDA Devices Moderate Dec 30, 2015

Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency

Siemens Healthcare Diagnostics, Inc.

FDA Devices Low Dec 30, 2015

DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

Siemens Medical Solutions USA, Inc

FDA Devices Critical Dec 30, 2015

Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

Biomerieux

FDA Devices Low Dec 30, 2015

Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

Ameditech Inc

FDA Devices Critical Dec 30, 2015

Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 Guiding Sheath 6F, 45 cm, ST, TB H74939277645120 Guiding Sheath 6F, 45 cm, MP, CC H74939277645210 Guiding Sheath 6F, 45 cm, MP, TB H74939277645220 Guiding Sheath 6F, 65 cm, ST, CC H74939277665110 Guiding Sheath 6F, 65

Boston Scientific Corporation

FDA Devices Moderate Dec 30, 2015

Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.

Aesculap, Inc.

FDA Devices Moderate Dec 30, 2015

BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore,

Becton Dickinson & Company

FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

Ameditech Inc

FDA Devices Low Dec 30, 2015

THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card, Item No. PSD-8P

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

Philips Electronics North America Corporation

FDA Devices Low Dec 30, 2015

ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.

Biomet, Inc.

FDA Devices Low Dec 30, 2015

Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W

Ameditech Inc

FDA Devices Low Dec 30, 2015

DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D

Ameditech Inc

FDA Devices Low Dec 30, 2015

DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

BC Group International Inc

FDA Devices Low Dec 30, 2015

DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU

Ameditech Inc

FDA Devices Low Dec 30, 2015

ProScreen 12 Panel Dip Card, Item No. PSD-12BUP

Ameditech Inc

FDA Devices Moderate Dec 30, 2015

IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic

Boston Scientific Corp

Nearby Recall Years

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

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.