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 6 critical, 44 moderate, and 0 lower-severity recalls. The page references 29 distinct recalling firms operating in 6 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (38), CPSC (8), NHTSA (3), 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 Devices Moderate Aug 6, 2025

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotom

Implant Direct Sybron Manufacturing LLC

FDA Devices Moderate Aug 6, 2025

Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;

Philips North America

FDA Devices Moderate Aug 6, 2025

Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter b

INSTITUT GEORGES LOPEZ

FDA Devices Moderate Aug 6, 2025

Upgrade to MR 7700 Model Number (REF): 782130;

Philips North America

FDA Devices Moderate Aug 6, 2025

Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;

Philips North America

FDA Devices Moderate Aug 6, 2025

Blood/MacConkey Biplate 100/PK, Product Number R02049

Remel, Inc

FDA Devices Moderate Aug 6, 2025

Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

Phasor Health, LLC

FDA Devices Critical Aug 6, 2025

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

Hamilton Medical AG

FDA Devices Moderate Aug 6, 2025

Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);

Philips North America

FDA Devices Moderate Aug 6, 2025

Strep Selective II Agar, Product Number R01859

Remel, Inc

FDA Devices Moderate Aug 6, 2025

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

Philips North America

FDA Devices Critical Aug 6, 2025

SafeStar 60A Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

FDA Devices Moderate Aug 6, 2025

SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;

Philips North America

FDA Devices Moderate Aug 6, 2025

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

Fresenius Kabi USA, LLC

FDA Devices Moderate Aug 6, 2025

Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.

Volcano Corp

FDA Devices Moderate Aug 6, 2025

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model N

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Aug 6, 2025

HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)

HeartSine Technologies Ltd

FDA Devices Moderate Aug 6, 2025

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

FUJIFILM Healthcare Americas Corporation

FDA Devices Moderate Aug 6, 2025

Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;

Philips North America

FDA Devices Moderate Aug 6, 2025

Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;

Philips North America

FDA Devices Moderate Aug 6, 2025

Intera 3.0T Quasar Dual Model Number (REF): 781150;

Philips North America

FDA Devices Moderate Aug 6, 2025

Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

Philips North America

FDA Devices Moderate Aug 6, 2025

SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

Philips North America

FDA Devices Moderate Aug 6, 2025

Molding Equipment. WCM series. Model WCM-330GL-i

Apic Yamada America

FDA Devices Moderate Aug 6, 2025

IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

LTS Therapy Systems, LLC

FDA Devices Moderate Aug 6, 2025

Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

Maquet Cardiopulmonary Gmbh

FDA Devices Moderate Aug 6, 2025

MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;

Philips North America

FDA Devices Moderate Aug 6, 2025

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

LTS Therapy Systems, LLC

FDA Devices Moderate Aug 6, 2025

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

Microbiologics Inc

FDA Devices Moderate Aug 6, 2025

LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

Fresenius Kabi USA, LLC

FDA Devices Moderate Aug 6, 2025

SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 6, 2025

LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.

Fresenius Kabi USA, LLC

FDA Devices Moderate Aug 6, 2025

Blood/EMB, Levine 100/PK, Product Number R02041

Remel, Inc

FDA Devices Moderate Aug 6, 2025

Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

Philips North America

FDA Devices Moderate Aug 6, 2025

Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R

Remote Diagnostic Technologies Ltd.

FDA Devices Moderate Aug 6, 2025

Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

Capnia Inc

FDA Devices Moderate Aug 6, 2025

LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

MICROVENTION INC.

FDA Devices Critical Aug 6, 2025

HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.

Draeger, Inc.

NHTSA No agency class Aug 6, 2025

FREIGHTLINER 2022-2023: STEERING

FREIGHTLINER

NHTSA No agency class Aug 6, 2025

INTERNATIONAL 2018-2025: SERVICE BRAKES, HYDRAULIC:FLUID

INTERNATIONAL

NHTSA No agency class Aug 5, 2025

INTERNATIONAL 2024-2025: SERVICE BRAKES, AIR

INTERNATIONAL

CPSC No agency class Jul 31, 2025

Amazon Recalls Amazon Basics Premium Foam Eurotop Mattresses Due to Fire Hazard; Violates Federal Standard for Mattress Flammability; Sold on Amazon

3Z Brands, of Glendale, Arizona

CPSC No agency class Jul 31, 2025

Baby Loren Recalls Morning Children's Loungewear Due to Serious Risk of Injury or Death from Burns; Violation of Federal Flammability Standards for Children's Sleepwear

DanLoren Group, dba Baby Loren, of Tracy, California

CPSC No agency class Jul 31, 2025

Backyard Kids Recalls KidKraft Farm to Table Play Kitchens Due to Strangulation Hazard; One Death Reported

KidKraft Inc., of Dallas, Texas

CPSC No agency class Jul 31, 2025

Dorel Home Furnishings Recalls Cosco 2-Step Kitchen Steppers Due to Fall and Injury Hazards

CPSC No agency class Jul 31, 2025

IKEA Recalls Garlic Presses Due to Laceration and Ingestion Hazards

IKEA US Retail LLC, of Woodbridge, Virginia

CPSC No agency class Jul 31, 2025

Leatherman Recalls Charge Plus Multi-Tools Due to Laceration Hazard

Leatherman Tool Group Inc., of Portland, Oregon

CPSC No agency class Jul 31, 2025

Tegu Recalls Magnetic Floating Stackers Toys Due to Magnet Ingestion Hazard; Risk of Serious Injury or Death; Violates Mandatory Standard for Toy Magnets

Tegu Holdings Inc., of Naples, Florida

CPSC No agency class Jul 31, 2025

TTI Consumer Power Tools Recalls RIDGID Framing Nailers Due to Laceration Hazard

FDA Food Moderate Jul 30, 2025

Turkeyfoot Creek Creamery Cacao Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid

Turkeyfoot Creek Creamery LLC

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.