PlainRecalls

2025 Recalls

5,015 recalls · Page 19 of 101

2025 Recall Year Insight

Federal agencies issued 5,015 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 5.97% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 13.7 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 101 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 22 distinct recalling firms operating in 5 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (34), CPSC (13), 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Devices Critical Nov 5, 2025

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT0911…

BALT USA, LLC

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Port REF: CL2100

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated…

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…

Alcon Research LLC

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer R…

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Bag Spike REF: CL-10

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See…

Alcon Research LLC

FDA Devices Moderate Nov 5, 2025

Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

Trial Tampon Box; Model Number: FG-TMP-REF04050504;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

ICU Medical, Inc.

FDA Devices Critical Nov 5, 2025

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Sof…

Dexcom, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00

CareFusion 303, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Closed Vial Spike REF: CL-80

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

MicroSurgical Technology Inc

FDA Devices Moderate Nov 5, 2025

Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Fresenius Kabi USA, LLC

FDA Devices Moderate Nov 5, 2025

Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system

Surgical Theater Inc

FDA Devices Moderate Nov 5, 2025

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

ICU Medical, Inc.

FDA Devices Critical Nov 5, 2025

IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

IMPRIS Imaging Inc

FDA Devices Moderate Nov 5, 2025

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Greiner Bio-One North America, Inc.

NHTSA Critical Nov 5, 2025

FREIGHTLINER 2020-2025: SUSPENSION:CRITICAL FASTENERS

FREIGHTLINER

NHTSA Critical Oct 31, 2025

BMW 2000-2001: AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE

BMW

NHTSA Critical Oct 31, 2025

KIA 2025: TIRES:TEMPORARY/EMERGENCY SPARE TIRE

KIA

CPSC Moderate Oct 30, 2025

5-in-1 Convertible High Chairs Recalled Due to Risk of Serious Injury or Death from Fall and Entrapment Hazards; Violates Mandatory Standard for High…

CPSC Moderate Oct 30, 2025

Avenco and Novilla Mattresses Recalled Due to Risk of Serious Injury or Death from Fire; Violates Mandatory Flammability Standard for Mattresses; Man…

PT Champion Mattress Indonesia Manufacturing, of Indonesia

CPSC Moderate Oct 30, 2025

Crate & Barrel Recalls Ana Dining Chairs Due to Fall Hazard

CPSC Moderate Oct 30, 2025

DINBooonLUX 12-Inch Full Size Mattresses Recalled Due to Risk of Serious Injury or Death from Fire; Violates Mandatory Standard for Mattress Flammabi…

Huizhou Dingbang E-Commerce Co., Ltd. dba DINBooonLUX, of China

CPSC Moderate Oct 30, 2025

Grundens Recalls Youth Jackets with Drawstrings Due to Strangulation Hazard; Risk of Serious Injury or Death

CPSC Moderate Oct 30, 2025

H-E-B Recalls 12-Pack Destination Holiday Glow Light Stick Bracelets Due to Skin Irritation Hazard

CPSC Moderate Oct 30, 2025

HOMEAL Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment; Violates Mandatory Standard for Children's Portable Bed Rails; Sold…

Shenzhen Speeding Culture Communication Co. Ltd., dba HOMEAL, of China

CPSC Moderate Oct 30, 2025

Knog Recalls Bicycle Lights Due to Fire and Burn Hazards

CPSC Moderate Oct 30, 2025

Milwaukee Tool Recalls M18 FUEL 14" and 12" Top Handle Chainsaws Due to Laceration Hazard

Milwaukee Electric Tool Corp., of Brookfield, Wisconsin

CPSC Moderate Oct 30, 2025

Modera Recalls Modera Pack N Play Mattresses Due to Risk of Serious Injury or Death from Entrapment; Violates Mandatory Standard for Crib Mattresses

CPSC Moderate Oct 30, 2025

Polaris Industries Recalls Model Year 2025-2026 Ranger XP 1000 NorthStar and Ranger Crew XP 1000 NorthStar Recreational Off-Road Vehicles (ROVs) Due …

Polaris Industries Inc., of Medina, Minnesota

CPSC Moderate Oct 30, 2025

The Kroger Co. Recalls Halloween-Themed Skeleton Wax Candles Due to Fire Hazard

The Kroger Co., of Cincinnati, Ohio

CPSC Moderate Oct 30, 2025

Werner Paddles Recalls Kayak Paddles Bracelets Due to Drowning Hazard

Werner Paddles, of Tennessee

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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2025