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, 41 moderate, and 2 lower-severity recalls. The page references 22 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (42), FDA Drug (8), 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 Drug Moderate Aug 20, 2025

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

Ascend Laboratories, LLC

FDA Drug Moderate Aug 20, 2025

Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01

Glenmark Pharmaceuticals Inc., USA

FDA Drug Moderate Aug 20, 2025

Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

FDA Drug Moderate Aug 20, 2025

Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.

Pfizer

FDA Drug Moderate Aug 20, 2025

Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10

Westminster Pharmaceuticals LLC

FDA Drug Moderate Aug 20, 2025

Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10

Westminster Pharmaceuticals LLC

FDA Drug Moderate Aug 20, 2025

Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05

Glenmark Pharmaceuticals Inc., USA

FDA Drug Moderate Aug 20, 2025

Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)

Merck & Co. Inc

FDA Devices Moderate Aug 20, 2025

GE Signa Artist, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Low Aug 20, 2025

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Diversatek Healthcare

FDA Devices Moderate Aug 20, 2025

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW

SPINEART SA

FDA Devices Critical Aug 20, 2025

Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

Baxter Healthcare Corporation

FDA Devices Moderate Aug 20, 2025

GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloo

Insightra Medical Inc

FDA Devices Moderate Aug 20, 2025

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Encore Medical, LP

FDA Devices Moderate Aug 20, 2025

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS

Carefree Surgical Specialties

FDA Devices Moderate Aug 20, 2025

GE Signa Voyager, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Encore Medical, LP

FDA Devices Moderate Aug 20, 2025

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes

Carefree Surgical Specialties

FDA Devices Critical Aug 20, 2025

Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator

Ambu Inc.

FDA Devices Moderate Aug 20, 2025

GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

Spark Biomedical Inc

FDA Devices Moderate Aug 20, 2025

GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.

Trinity Biotech USA

FDA Devices Moderate Aug 20, 2025

HemosIL LMW Heparin Controls; Part Number: 0020300200;

Instrumentation Laboratory

FDA Devices Critical Aug 20, 2025

DreamStation Auto BiPAP. Non-Continuous Ventilator.

Philips Respironics, Inc.

FDA Devices Moderate Aug 20, 2025

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

Boston Scientific Corporation

FDA Devices Critical Aug 20, 2025

DreamStation Auto. Non-Continuous Ventilator.

Philips Respironics, Inc.

FDA Devices Moderate Aug 20, 2025

GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Low Aug 20, 2025

Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK MINI 2HH-1FM/169-107, BD PYXIS MEDBANK MINI 2HH-1FH/169-106, BD PYXIS MEDBANK MINI 2FM/169-105, BD PYXIS MEDBANK MINI 2FH/169-104, BD PYXIS MEDBANK MINI 1HH-3HM/169-103, BD PYXIS

CareFusion 303, Inc.

FDA Devices Moderate Aug 20, 2025

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS

Carefree Surgical Specialties

FDA Devices Moderate Aug 20, 2025

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No

SPINEART SA

FDA Devices Moderate Aug 20, 2025

GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Critical Aug 20, 2025

Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while

Thoratec LLC

FDA Devices Moderate Aug 20, 2025

GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Aug 20, 2025

GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 20, 2025

GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Moderate Aug 20, 2025

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes

Carefree Surgical Specialties

FDA Devices Moderate Aug 20, 2025

GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

FDA Devices Critical Aug 20, 2025

DreamStation Auto CPAP. Non-Continuous Ventilator.

Philips Respironics, Inc.

FDA Devices Moderate Aug 20, 2025

Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 20, 2025

High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

Merit Medical Systems, Inc.

FDA Devices Critical Aug 20, 2025

Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SC

Boston Scientific Corporation

FDA Devices Moderate Aug 20, 2025

Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

Waldemar Link GmbH & Co. KG (Mfg Site)

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.