PlainRecalls

2025 Recalls

5,015 recalls · Page 36 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 19 critical, 30 moderate, and 1 lower-severity recalls. The page references 26 distinct recalling firms operating in 4 distinct product categories, with 45 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (42), NHTSA (5), CPSC (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 Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Softwar…

RAYSEARCH LABORATORIES AB

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left …

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Ve…

RAYSEARCH LABORATORIES AB

FDA Devices Critical Sep 10, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version:…

Dexcom, Inc.

FDA Devices Moderate Sep 10, 2025

Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum …

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate Sep 10, 2025

Medshape Universal Joints, REF: DNE-9000-UJ

Medshape, INC.

FDA Devices Moderate Sep 10, 2025

Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF…

Boston Scientific Neuromodulation Corporation

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Softwar…

RAYSEARCH LABORATORIES AB

FDA Devices Critical Sep 10, 2025

WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WA…

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software V…

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Sep 10, 2025

Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

ICU Medical Inc.

FDA Devices Moderate Sep 10, 2025

InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Medtronic MiniMed, Inc.

FDA Devices Critical Sep 10, 2025

Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

Baxter Healthcare Corporation

FDA Devices Moderate Sep 10, 2025

LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated…

Physio-Control, Inc.

FDA Devices Critical Sep 10, 2025

WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left …

Boston Scientific Corporation

FDA Devices Moderate Sep 10, 2025

Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit co…

ICU Medical Inc.

FDA Devices Moderate Sep 10, 2025

LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-0000…

Physio-Control, Inc.

FDA Devices Critical Sep 10, 2025

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Vers…

Dexcom, Inc.

FDA Devices Moderate Sep 10, 2025

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational pr…

CARIS LIFE SCIENCES

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-grad…

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,…

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…

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 WATC…

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:…

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, Softwar…

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…

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. …

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 WATC…

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(…

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 331706400…

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, Softwa…

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…

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:…

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…

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 immunoass…

Bio-Rad Laboratories, Inc.

NHTSA Critical Sep 9, 2025

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

ALFA ROMEO

NHTSA Critical Sep 5, 2025

HONDA 2021-2022: ELECTRICAL SYSTEM:MOTORCYCLE HANDLEBAR SWITCH POD LEFT/RIGHT

HONDA

NHTSA Critical Sep 5, 2025

ACURA 2025: STEERING:ELECTRIC POWER ASSIST SYSTEM

ACURA

CPSC Moderate Sep 4, 2025

Makita U.S.A., Inc. Recalls Cordless Grease Guns and Grease Gun Hoses Due to Laceration Hazard

CPSC Moderate Sep 4, 2025

StopBox USA Recalls AR-15 Chamber Lock Pros Due to Risk of Serious Injury and Death

StopBox USA, of Spokane Valley, Washington

CPSC Moderate Sep 4, 2025

URMYWO Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation and Fall Hazard; Violates Mandatory Standard for Infant Sleep P…

Dong Guan Bo Mo Na Ke Ji You Xian Gong Si, of China, doing business as Pomona

NHTSA Critical Sep 4, 2025

LEXUS 2023-2025: VISIBILITY:DEFROSTER/DEFOGGER/HVAC SYSTEM

LEXUS

NHTSA Critical Sep 4, 2025

JEEP 2022-2025: ELECTRICAL SYSTEM:PROPULSION SYSTEM

JEEP

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