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, 49 moderate, and 1 lower-severity recalls. The page references 8 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 Moderate Sep 9, 2015

GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED 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

O.B. PACK HOSPITAL 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

ANGIODRAPE PACK DAMAS 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

UROLOGY 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

Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.

Transonic Systems Inc

FDA Devices Low Sep 9, 2015

FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

Abbott Electrophysiology

FDA Devices Moderate Sep 9, 2015

SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.

Limacorporate S.p.A

FDA Devices Moderate Sep 9, 2015

Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.

Transonic Systems Inc

FDA Devices Moderate Sep 9, 2015

LITHOTOMY 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

FDA Devices Moderate Sep 9, 2015

UTILITY DRAPE END PRODUCT 50PK/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

Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

Covidien LLC

FDA Devices Moderate Sep 9, 2015

Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.

Transonic Systems Inc

FDA Devices Moderate Sep 9, 2015

LAP-CHOLECYSTECTOMY 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

CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x 24 mm, REF CCP-L3024; 3.0 x 26 mm, REF CCP-L3026; 3.0 x 28 mm, REF CCP-L3028; 3.0 x 30 mm, REF CCP-L3030; 3.0 x 32 mm, REF CCP-L3032; 3.0 x 34mm, REF CCP-L3034; 3.0 x 36 mm, REF CCP-L3036; 3.0 x 38 mm, REF CCP-L3038; 3.0

Wright Medical Technology, Inc.

FDA Devices Moderate Sep 9, 2015

PREMIUM CESAREAN PACK 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

SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed, Inc

FDA Devices Moderate Sep 9, 2015

Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter Inc.

FDA Devices Moderate Sep 9, 2015

Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.

Transonic Systems Inc

FDA Devices Moderate Sep 9, 2015

SUCTION CATHETER KIT 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

TRACHEOTOMY CARE KIT 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

GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED 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

OPEN HEART TRAY CUSTOMED 1/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

(1) (2) 10/CS CUSTOMED 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

UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/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

LAPAROSC. OB GYN 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

LUMBAR 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

FACE PACK MRT 8/CS CUSTOMED 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

CENTRAL LINE FULL BODY DRAPE CUSTOMED 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

KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 22113) 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

Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.

Transonic Systems Inc

FDA Devices Moderate Sep 9, 2015

EAR 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

ARTHROSCOPY SURGICAL PACK 4/C 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

BREAST PACK-TPSC 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

ARTHROSCOPY 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

C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

Customed, Inc

FDA Devices Moderate Sep 9, 2015

OPEN HEART TRAY 1/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

FACE PACK FJG 8/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* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) 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

KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction System for Neonates/Pediatrics, 10 F, Elbow (Product Code 2103); KimVent* Closed Suction Systems for Neonates/Pediatrics, 8 F, Elbow (Product Code 8313); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (P

Halyard Health, Inc

FDA Devices Moderate Sep 9, 2015

KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056); KimVent* Wet Pak* Closed Suction System for Adults, 16 F, T-Piece (Product Code 22556); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22012356) 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

SHOULDER 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

KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135) 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

EAR 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

PEDIATRIC LAP PACK 8/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

LAPAROTOMY PACK CS/6 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

OB PACK CS/4 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

E.N.T. PK 7/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

FEMORAL 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

IMPLANTE DE ORTHOPEDIA 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

BREAST PACK-BOD 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

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.