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 17 critical, 33 moderate, and 0 lower-severity recalls. The page references 28 distinct recalling firms operating in 6 distinct product categories, with 35 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (21), NHTSA (15), CPSC (12), 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 Jun 18, 2025

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

Beckman Coulter, Inc.

FDA Devices Moderate Jun 18, 2025

Intera 1.5T Achieva Nova Product Number: 781172;

Philips North America

FDA Devices Moderate Jun 18, 2025

Intera Achieva 1.5T Pulsar; Product Number: 781171;

Philips North America

FDA Devices Moderate Jun 18, 2025

MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.

GE Medical Systems Information Technologies Inc

FDA Devices Critical Jun 18, 2025

Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Zyno Medical LLC

FDA Devices Moderate Jun 18, 2025

Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to create precision incisions in vitrectomy procedures. Component: No

Tecfen Medical

FDA Devices Moderate Jun 18, 2025

Intera 1.5T Master/Nova Product Number: 781106;

Philips North America

FDA Devices Moderate Jun 18, 2025

Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No

Tecfen Medical

FDA Devices Critical Jun 18, 2025

Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Zyno Medical LLC

FDA Devices Moderate Jun 18, 2025

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Jun 18, 2025

Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate Jun 18, 2025

Intera 1.5T Omni/Stellar; Product Number: 781104;

Philips North America

FDA Devices Moderate Jun 18, 2025

OEC 3D

GE Medical Systems, LLC

FDA Devices Moderate Jun 18, 2025

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A

Olympus Corporation of the Americas

FDA Devices Moderate Jun 18, 2025

Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No

Tecfen Medical

FDA Devices Moderate Jun 18, 2025

Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-JA (Japan Only), TFL-FBX200R-JA (Japan Only), TFL-FBX550R-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through

Olympus Corporation of the Americas

FDA Devices Moderate Jun 18, 2025

Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)

Turncare, Inc

FDA Devices Moderate Jun 18, 2025

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

Philips North America

FDA Devices Moderate Jun 18, 2025

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No

Olympus Corporation of the Americas

FDA Devices Moderate Jun 18, 2025

LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS

American Contract Systems, Inc.

FDA Devices Moderate Jun 18, 2025

BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006

BD SWITZERLAND SARL

CPSC No agency class Jun 18, 2025

AstroAI Recalls Minifridges Due to Fire and Burn Hazards; Two Resulted in More Than $360,000 in Reported Property Damages

Shaoxing ShangYu North Electron Manufacture Co. Ltd., of China

CPSC No agency class Jun 18, 2025

Crayan Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard ; Violation of Federal Standard for Mattress Flammability; Sold Exclusively on Amazon by Crayan

Foshanshi Liyue Jiaju Youxian Gongsi, dba Crayan Inc., of China

CPSC No agency class Jun 18, 2025

MaxKare Electric Blankets Recalled Due to Burn and Fire Hazards; Manufactured by Yumo and Sold Exclusively on Walmart.com

Shenzhen Yumo Commerce and Trade Corporation, of China

CPSC No agency class Jun 18, 2025

Polaris Recalls Ranger XP Kinetic and Pro XD Kinetic Recreational Off-Highway Vehicles (ROVs) Due to Fire Hazard

Polaris Industries Inc., of Medina, Minnesota

CPSC No agency class Jun 18, 2025

TADAKAZU Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation, Fall and Entrapment Hazards; Violations of Federal Standard for Infant Sleep Products; Sold on Amazon

Sichuanyongzhichengguojimaoyiyouxiangongsi, d/b/a TADAKAZU, of China

CPSC No agency class Jun 18, 2025

YaFiti White Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon

Shenzhen Leader-Union Technology Co. Ltd., of China

NHTSA No agency class Jun 18, 2025

MAZDA 2025: AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE:SOFTWARE

MAZDA

NHTSA No agency class Jun 18, 2025

TESLA 2026: SEATS:CRITICAL FASTENERS

TESLA

USDA FSIS Critical Jun 17, 2025

FreshRealm Recalls Chicken Fettuccine Alfredo Products Due to Possible Listeria Contamination

FreshRealm

NHTSA No agency class Jun 13, 2025

LINCOLN 2020-2025: STRUCTURE:BODY

LINCOLN

NHTSA No agency class Jun 13, 2025

FORD 2021-2025: ELECTRICAL SYSTEM:BODY CONTROL MODULE:SOFTWARE

FORD

NHTSA No agency class Jun 13, 2025

LINCOLN 2022: EXTERIOR LIGHTING:LIGHTING CONTROL MODULE:SOFTWARE

LINCOLN

NHTSA No agency class Jun 13, 2025

FORD 2025: SERVICE BRAKES, HYDRAULIC:PEDALS AND LINKAGES

FORD

NHTSA No agency class Jun 13, 2025

FORD 2025: ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL

FORD

NHTSA No agency class Jun 13, 2025

FORD 2025: ELECTRICAL SYSTEM:WIRING

FORD

NHTSA No agency class Jun 13, 2025

FORD 2025: LATCHES/LOCKS/LINKAGES:DOORS:LOCK

FORD

NHTSA No agency class Jun 13, 2025

FORD 2025: AIR BAGS:FRONTAL

FORD

NHTSA No agency class Jun 13, 2025

FORD 2025: POWER TRAIN:AUTOMATIC TRANSMISSION:INTERNAL:PARK PAWL

FORD

NHTSA No agency class Jun 13, 2025

FORD,LINCOLN 2020-2025: SEATS:MID/REAR ASSEMBLY

FORD,LINCOLN

NHTSA No agency class Jun 13, 2025

FORD 2025: ENGINE AND ENGINE COOLING:ENGINE:HARD PARTS INTERNAL/MECHANICAL

FORD

USDA FSIS Critical Jun 13, 2025

King Tallow LLC Recalls Beef Tallow Products Produced Without Benefit of Inspection

CPSC No agency class Jun 12, 2025

Agro Superior Group Recalls Oliver & Smith Mattresses Due to Risk of Serious Injury or Death from Fire Hazard; Violation of Federal Standard for Mattress Flammability

CPSC No agency class Jun 12, 2025

Bugaboo North America Recalls Giraffe High Chairs Due to Risk of Serious Injury or Death from Fall Hazard

CPSC No agency class Jun 12, 2025

Endless Pools Recalls Manual Retractable Pool Covers Due to Drowning and Entrapment Hazards; Risk of Serious Injury and Death

Endless Pools, of Aston, Pennsylvania

CPSC No agency class Jun 12, 2025

Mammut Sports Group Recalls Skywalker Pro Via Ferrata Sets Due to Risk of Serious Injury or Death from Fall Hazard

CPSC No agency class Jun 12, 2025

More than One Million Anker Power Banks Recalled Due to Fire and Burn Hazards; Manufactured by Anker Innovations

Anker Innovations Limited, of China

CPSC No agency class Jun 12, 2025

TTI Outdoor Power Equipment Recalls RYOBI 40-Volt 24-Inch Cordless Hedge Trimmers Due to Laceration Hazard

NHTSA No agency class Jun 12, 2025

VOLVO 2023-2026: SERVICE BRAKES, HYDRAULIC:POWER ASSIST:ELECTRIC:CONTROL MODULE:SOFTWARE

VOLVO

NHTSA No agency class Jun 12, 2025

ACURA,HONDA 2021-2025: SERVICE BRAKES, HYDRAULIC:PEDALS AND LINKAGES

ACURA,HONDA

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.