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 0 critical, 48 moderate, and 2 lower-severity recalls. The page references 12 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (39), FDA Drug (11), 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 Drug Moderate Sep 9, 2015

Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA

South Coast Specialty Compounding, Inc.

FDA Drug Low Sep 9, 2015

ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28

Qualitest Pharmaceuticals

FDA Drug Moderate Sep 9, 2015

Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Moderate Sep 9, 2015

Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Moderate Sep 9, 2015

Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Moderate Sep 9, 2015

Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Moderate Sep 9, 2015

Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Moderate Sep 9, 2015

Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Moderate Sep 9, 2015

Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Moderate Sep 9, 2015

Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc.

FDA Drug Low Sep 9, 2015

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

Silarx Pharmaceutical, Inc.

FDA Devices Moderate Sep 9, 2015

LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

MINOR PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Panoramic Rental Corp.

FDA Devices Moderate Sep 9, 2015

PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

SURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter

C.R. Bard, Inc.

FDA Devices Moderate Sep 9, 2015

Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.

Pointe Scientific, Inc.

FDA Devices Moderate Sep 9, 2015

NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Covidien LLC

FDA Devices Moderate Sep 9, 2015

LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22103); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22714183) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

LAPAROTOMY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC

Covidien LLC

FDA Devices Moderate Sep 9, 2015

Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.

Transonic Systems Inc

FDA Devices Moderate Sep 9, 2015

WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022; 3.0 x 24 mm, REF CCP-N3024; 3.0 x 26 mm, REF CCP-N3026; 3.0 x 28 mm, REF CCP-N3028; 3.0 x 30 mm, REF CCP-N3030; 3.0 x 32 mm, REF CCP-N3032; 3.0 x 34 mm, REF CCP-N3034; 3.0 x 36 mm, REF CCP-N3036; 3.0 x 38 mm, REF CCP-N3038;

Wright Medical Technology, Inc.

FDA Devices Moderate Sep 9, 2015

HAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Covidien LLC

FDA Devices Moderate Sep 9, 2015

LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Covidien LLC

FDA Devices Moderate Sep 9, 2015

LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

PERY-GYN SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.

Volcano Corporation

FDA Devices Moderate Sep 9, 2015

PERI GYN PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Customed, Inc

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.