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 22 critical, 27 moderate, and 1 lower-severity recalls. The page references 21 distinct recalling firms operating in 3 distinct product categories, with 47 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (47), NHTSA (2), USDA FSIS (1), 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 Sep 10, 2025

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24

ICU Medical Inc.

FDA Devices Critical Sep 10, 2025

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Medtronic Perfusion Systems

FDA Devices Moderate Sep 10, 2025

Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Sep 10, 2025

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24

ICU Medical Inc.

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 100% Leptospermum Honey. As wound exudate is absorbed, the dressing wh

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump

Baxter Healthcare Corporation

FDA Devices Critical Sep 10, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app Component: Dexcom G7 CGM iOS App

Dexcom, Inc.

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

Micro Joystick R-net. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Moderate Sep 10, 2025

RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 i

Reflexion Medical, Inc.

FDA Devices Moderate Sep 10, 2025

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm

Physio-Control, Inc.

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Sep 10, 2025

Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedu

Merge Healthcare, Inc.

FDA Devices Critical Sep 10, 2025

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

Dexcom, Inc.

FDA Devices Moderate Sep 10, 2025

NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

Preat Corp

FDA Devices Low Sep 10, 2025

FloPatch FP120, REF: FP120-FOT01-005

Flosonics Medical (R/A 1929803 ONTARIO CORP.)

FDA Devices Moderate Sep 10, 2025

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, M

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Sep 10, 2025

Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

Bio-Rad Laboratories, Inc.

FDA Devices Moderate Sep 10, 2025

Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)

Visgeneer, Inc.

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH a

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump

Baxter Healthcare Corporation

FDA Devices Moderate Sep 10, 2025

TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

PREMIA SPINE LTD

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 100%, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

IDM-ARLITE-R. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System

Dexcom, Inc.

FDA Devices Critical Sep 10, 2025

All-round Joystick R-net Light. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Critical Sep 10, 2025

IDM-MULTI-R. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

O&M HALYARD INC

FDA Devices Critical Sep 10, 2025

Multi Joystick R-net. Electrical wheelchair component.

mo-Vis BVBA

FDA Devices Moderate Sep 10, 2025

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Mo

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24

ICU Medical Inc.

FDA Devices Critical Sep 10, 2025

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

Medtronic Perfusion Systems

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

NHTSA No agency class Sep 10, 2025

VOLVO 2026: SEAT BELTS:FRONT:RETRACTOR

VOLVO

USDA FSIS Moderate Sep 10, 2025

FSIS Issues Public Health Alert for Raw Sirloin Beef Tip Product Due to Misbranding and Undeclared Allergens

Bianco Inc.

NHTSA No agency class Sep 9, 2025

ALFA ROMEO 2017-2019: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP

ALFA ROMEO

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.