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, 43 moderate, and 0 lower-severity recalls. The page references 24 distinct recalling firms operating in 7 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (29), CPSC (15), NHTSA (5), 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 Nov 5, 2025

ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

Vantive US Healthcare LLC

FDA Devices Moderate Nov 5, 2025

9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

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 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE 8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Al

Alcon Research LLC

FDA Devices Moderate Nov 5, 2025

Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Nov 5, 2025

Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

ChemoLock Bag Spike, 01 units REF: CL-10-10

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

Microgenics Corporation

FDA Devices Critical Nov 5, 2025

IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

IMPRIS Imaging Inc

FDA Devices Moderate Nov 5, 2025

ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

ENDOMAGNETICS LTD

FDA Devices Moderate Nov 5, 2025

ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

ICU Medical, Inc.

FDA Devices Moderate Nov 5, 2025

All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A

Aesculap Inc

FDA Devices Moderate Nov 5, 2025

Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A

Aesculap Inc

FDA Devices Moderate Nov 5, 2025

Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;

DAYE (ANNE'S DAY LTD)

FDA Devices Moderate Nov 5, 2025

Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;

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 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products ar

Alcon Research LLC

FDA Devices Moderate Nov 5, 2025

All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00

CareFusion 303, Inc.

FDA Devices Moderate Nov 5, 2025

Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 138919-01 138920-01 138921-01 138922-01 138923-01 138924-01 138926-01 138927-01 138928-01 138929-01 138930-01 138931-01 138932-01 138933-01 138934-01 138936-01 138937-01 138938-01 138939-01 138940-01 13

CareFusion 303, Inc.

NHTSA No agency class Nov 5, 2025

FREIGHTLINER,WESTERN STAR 2020-2025: SUSPENSION:CRITICAL FASTENERS

FREIGHTLINER,WESTERN STAR

USDA FSIS Critical Nov 4, 2025

Brazilian Taste Recalls Frozen Chicken and Beef Croquette Products Due to Misbranding and an Undeclared Allergen

Brazilian Taste

NHTSA No agency class Nov 3, 2025

VOLVO 2026: EXTERIOR LIGHTING

VOLVO

NHTSA No agency class Nov 3, 2025

VOLVO 2023: SEAT BELTS:FRONT:ANCHORAGE

VOLVO

NHTSA No agency class Oct 31, 2025

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

BMW

NHTSA No agency class Oct 31, 2025

KIA 2025: TIRES:TEMPORARY/EMERGENCY SPARE TIRE

KIA

CPSC No agency class 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 Chairs; Imported by Harppa

CPSC No agency class Oct 30, 2025

Avenco and Novilla Mattresses Recalled Due to Risk of Serious Injury or Death from Fire; Violates Mandatory Flammability Standard for Mattresses; Manufactured by PT Champion

PT Champion Mattress Indonesia Manufacturing, of Indonesia

CPSC No agency class Oct 30, 2025

Crate & Barrel Recalls Ana Dining Chairs Due to Fall Hazard

CPSC No agency class 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 Flammability; Sold on Amazon by DINBooonLUX

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

CPSC No agency class Oct 30, 2025

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

CPSC No agency class Oct 30, 2025

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

CPSC No agency class 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 on Amazon by HOMEAL

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

CPSC No agency class Oct 30, 2025

Knog Recalls Bicycle Lights Due to Fire and Burn Hazards

CPSC No agency class 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 No agency class 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 No agency class 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 to Risk of Serious Injury from Fire Hazard

Polaris Industries Inc., of Medina, Minnesota

CPSC No agency class Oct 30, 2025

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

The Kroger Co., of Cincinnati, Ohio

CPSC No agency class Oct 30, 2025

Werner Paddles Recalls Kayak Paddles Bracelets Due to Drowning Hazard

Werner Paddles, of Tennessee

CPSC No agency class Oct 30, 2025

WLIVE Fabric Drawer Dressers Recall Expanded to Include 16-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by WLIVE

Jiangsu Zhi Pai Furniture Manufacturing Co., Ltd., of China

CPSC No agency class Oct 30, 2025

YaFiti Fabric 12-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by YaFiti

Xuzhou Mingquanhe Household Co., Ltd., of China

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.