PlainRecalls

2025 Recall Year Insight

Federal agencies issued 6,236 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 5.97% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 17.1 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 125 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 2025.

On this page of 50 records, severity classification shows 7 critical, 42 moderate, and 1 lower-severity recalls. The page references 17 distinct recalling firms operating in 2 distinct product categories, with 44 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (48), FDA Drug (2), 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 2025 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 Critical Jul 9, 2025

ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6

Church & Dwight Inc

FDA Drug Moderate Jul 9, 2025

Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0

The Harvard Drug Group LLC

FDA Devices Moderate Jul 9, 2025

Philips eL18-4 EMT Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.

Becton, Dickinson and Company, BD Bio Sciences

FDA Devices Moderate Jul 9, 2025

Philips C9-5EC Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Change Healthcare Cardiology Hemodynamics Software

CHANGE HEALTHCARE CANADA COMPANY

FDA Devices Critical Jul 9, 2025

Servo-u Ventilator System. Model Number: 6688600.

Maquet Critical Care AB

FDA Devices Moderate Jul 9, 2025

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

CORIN MEDICAL, LTD.

FDA Devices Moderate Jul 9, 2025

Philips eL18-4 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

C.R. Bard Inc

FDA Devices Critical Jul 9, 2025

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS

Philips Respironics, Inc.

FDA Devices Moderate Jul 9, 2025

Philips C5-2 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips L12-3 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips X6-1 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.

HemoCue AB

FDA Devices Moderate Jul 9, 2025

Philips X8-2t Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips V6-2 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jul 9, 2025

VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate Jul 9, 2025

Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jul 9, 2025

Philips S5-1 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips S7-2 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips 3D9-3v Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips X7-2t Transducer.

Philips Ultrasound, Inc

FDA Devices Low Jul 9, 2025

Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No

LUMITHERA INC

FDA Devices Moderate Jul 9, 2025

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 9, 2025

BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.

Philips Respironics, Inc.

FDA Devices Moderate Jul 9, 2025

Philips X5-1 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

interventional fluoroscopic x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 9, 2025

Philips S8-3t Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips XL14-3 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips C5-1 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120

C.R. Bard Inc

FDA Devices Moderate Jul 9, 2025

Philips L12-4 Transducer.

Philips Ultrasound, Inc

FDA Devices Critical Jul 9, 2025

Servo-n Ventilator System. Model Number: 6694800.

Maquet Critical Care AB

FDA Devices Moderate Jul 9, 2025

Change Healthcare Cardiology Hemo Software

CHANGE HEALTHCARE CANADA COMPANY

FDA Devices Moderate Jul 9, 2025

interventional fluoroscopic x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Critical Jul 9, 2025

BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.

Philips Respironics, Inc.

FDA Devices Moderate Jul 9, 2025

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 9, 2025

interventional fluoroscopic x-ray system

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jul 9, 2025

My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

Onkos Surgical, Inc.

FDA Devices Moderate Jul 9, 2025

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323

Hardy Diagnostics

FDA Devices Moderate Jul 9, 2025

REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.

Becton, Dickinson and Company, BD Bio Sciences

FDA Devices Moderate Jul 9, 2025

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Jul 9, 2025

Philips VL13-5 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

Philips L8-4 Transducer.

Philips Ultrasound, Inc

FDA Devices Moderate Jul 9, 2025

BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316

C.R. Bard Inc

FDA Devices Critical Jul 9, 2025

Servo-u MR Ventilator System. Model Number: 6888800.

Maquet Critical Care AB

FDA Devices Moderate Jul 9, 2025

ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e., patient extremities. This

Siemens Medical Solutions USA, Inc

Nearby Recall Years

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

Compare 2025 with 2024 →

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 2025

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 2025 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.