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 3 critical, 47 moderate, and 0 lower-severity recalls. The page references 14 distinct recalling firms operating in 1 distinct product categories, with 49 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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 Oct 29, 2025

Model Number 40KWFXPLUS.889, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Critical Oct 29, 2025

IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave,

ICU Medical, Inc.

FDA Devices Moderate Oct 29, 2025

Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

Synthes (USA) Products LLC

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

SM_40HF_BDC, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

RADPRO MOBILE, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

GE Medical Systems, LLC

FDA Devices Critical Oct 29, 2025

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Con

Abiomed, Inc.

FDA Devices Moderate Oct 29, 2025

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube

Wipro GE Healthcare Private Ltd.

FDA Devices Moderate Oct 29, 2025

DxI 9000 Access Immunoassay Analyzer, Part Number C11137

Beckman Coulter, Inc.

FDA Devices Moderate Oct 29, 2025

BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.

Becton Dickinson & Co.

FDA Devices Moderate Oct 29, 2025

Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Model Number 40KWMOBILE3.899, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number 40KWFXPLUS.005, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve

Cardinal Health 200, LLC

FDA Devices Moderate Oct 29, 2025

Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system

SEDECAL SA

FDA Devices Critical Oct 29, 2025

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

B BRAUN MEDICAL INC

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

Model Number 40KWFXPLUS.002, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.

Becton Dickinson & Co.

FDA Devices Moderate Oct 29, 2025

Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUM

Cardinal Health 200, LLC

FDA Devices Moderate Oct 29, 2025

Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.

Becton Dickinson & Co.

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number 40KWFXPLUS-710CW, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

LeMaitre Vascular, Inc.

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

SED URS LP, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Oct 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

UIH Technologies LLC

FDA Devices Moderate Oct 29, 2025

BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

Biomet, Inc.

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)

Beckman Coulter, Inc.

FDA Devices Moderate Oct 29, 2025

Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

Model Number 40KWFXPLUS, Mobile X-ray system

SEDECAL SA

FDA Devices Moderate Oct 29, 2025

LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

Synthes (USA) Products LLC

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.