PlainRecalls

2025 Recalls

5,015 recalls · Page 95 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, 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 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 8 critical, 37 moderate, and 5 lower-severity recalls. The page references 20 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 (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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Low Jan 22, 2025

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairf…

Akron Pharma, Inc.

FDA Drug Critical Jan 22, 2025

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

Alcon Research LLC

FDA Drug Low Jan 22, 2025

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71…

Akron Pharma, Inc.

FDA Drug Moderate Jan 22, 2025

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151…

Viatris Inc

FDA Drug Low Jan 22, 2025

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfie…

Akron Pharma, Inc.

FDA Drug Low Jan 22, 2025

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399…

Akron Pharma, Inc.

FDA Drug Moderate Jan 22, 2025

Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 5815…

Viatris Inc

FDA Drug Low Jan 22, 2025

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 11…

Akron Pharma, Inc.

FDA Devices Critical Jan 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model N…

Boston Scientific Corporation

FDA Devices Critical Jan 22, 2025

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Baxter Healthcare Corporation

FDA Devices Moderate Jan 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-…

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB632…

Coloplast Manufacturing US, LLC

FDA Devices Moderate Jan 22, 2025

8MM,MEGA SUTURECUT ND,IS4000 REF 471309

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DIL…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,PROGRASP FORCEPS,IS4000 REF 471093

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAU…

Sklar Instruments

FDA Devices Critical Jan 22, 2025

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the inst…

Olympus Corporation of the Americas

FDA Devices Moderate Jan 22, 2025

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

Cook Biotech, Inc.

FDA Devices Moderate Jan 22, 2025

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Hologic, Inc.

FDA Devices Moderate Jan 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refu…

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

SIN SISTEMA DE IMPLANTE NACIONAL S.A

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNED…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 22, 2025

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Impella RP Flex with SmartAssist; Product Number: 1000323;

Abiomed, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,LONG TIP FORCEPS,IS4000 REF 471048

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquade…

Nuwellis Inc

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK …

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK …

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery c…

Alcon Research LLC

FDA Devices Moderate Jan 22, 2025

GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N …

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA N…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, T…

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

Change Healthcare Cardiology Hemo software

A L I Technologies Ltd

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUE…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL …

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSE…

Sklar Instruments

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 — consumer product and vehicle recall feeds for 2025