PlainRecalls

2025 Recalls

5,015 recalls · Page 29 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 17 critical, 33 moderate, and 0 lower-severity recalls. The page references 19 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (47), FDA Drug (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 Drug Moderate Oct 8, 2025

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuti…

Zydus Pharmaceuticals (USA) Inc

FDA Drug Moderate Oct 8, 2025

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manu…

Apotex Corp.

FDA Drug Moderate Oct 8, 2025

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43…

Amerisource Health Services LLC

FDA Devices Moderate Oct 8, 2025

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Medtronic MiniMed, Inc.

FDA Devices Critical Oct 8, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202…

Siemens Medical Solutions USA, Inc

FDA Devices Critical Oct 8, 2025

Biograph mMR. Model Number: 10433372.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Oct 8, 2025

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT…

North American Rescue LLC.

FDA Devices Moderate Oct 8, 2025

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…

Northeast Scientific Inc.

FDA Devices Moderate Oct 8, 2025

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathe…

Northeast Scientific Inc.

FDA Devices Moderate Oct 8, 2025

Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Man…

MedicalCommunications GmbH

FDA Devices Moderate Oct 8, 2025

ZAP-X Radiosurgery System, Model: 300150

Zap Surgical Systems

FDA Devices Critical Oct 8, 2025

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an an…

Draeger, Inc.

FDA Devices Critical Oct 8, 2025

Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 40165…

Medline Industries, LP

FDA Devices Moderate Oct 8, 2025

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

Aesculap AG

FDA Devices Moderate Oct 8, 2025

NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…

Northeast Scientific Inc.

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

Getinge Disinfection Ab

FDA Devices Moderate Oct 8, 2025

Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006

Schiller, Ag

FDA Devices Critical Oct 8, 2025

MAGNETOM Verio. Model Number: 10276755.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Oct 8, 2025

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

Medline Industries, LP

FDA Devices Critical Oct 8, 2025

MAGNETOM Lumina (DE). Model Number: 11344916.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Oct 8, 2025

1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;

Howmedica Osteonics Corp.

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

Change Healthcare Radiology Solutions software version 14.2.2

CHANGE HEALTHCARE CANADA COMPANY

FDA Devices Moderate Oct 8, 2025

Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Oct 8, 2025

MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.

Siemens Medical Solutions USA, Inc

FDA Devices Critical Oct 8, 2025

Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RR…

Medline Industries, LP

FDA Devices Critical Oct 8, 2025

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Siemens Medical Solutions USA, Inc

FDA Devices Critical Oct 8, 2025

Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

Medline Industries, LP

FDA Devices Critical Oct 8, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

Siemens Medical Solutions USA, Inc

FDA Devices Critical Oct 8, 2025

MAGNETOM Vida Fit. Model Number: 11410481.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Oct 8, 2025

Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathe…

Northeast Scientific Inc.

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Oct 8, 2025

MAGNETOM Skyra fit. Model Number: 10849580.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Oct 8, 2025

Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Oct 8, 2025

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an …

Draeger, Inc.

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9…

LeMaitre Vascular, Inc.

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, sof…

bioMerieux, Inc.

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Moderate Oct 8, 2025

NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Ca…

Northeast Scientific Inc.

FDA Devices Critical Oct 8, 2025

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B

Medline Industries, LP

FDA Devices Moderate Oct 8, 2025

Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162…

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Devices Critical Oct 8, 2025

MAGNETOM Cima.X (DE). Model Number: 11647158.

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Oct 8, 2025

NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Cathet…

Northeast Scientific Inc.

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