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.
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.
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Alcon Research LLC
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.
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
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.
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.
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
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.
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
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
Baxter Healthcare Corporation
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-…
Augustine Temperature Management, LLC
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Intuitive Surgical, Inc.
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB632…
Coloplast Manufacturing US, LLC
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Intuitive Surgical, Inc.
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
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Intuitive Surgical, Inc.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Intuitive Surgical, Inc.
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
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
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Cook Biotech, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Hologic, Inc.
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refu…
Augustine Temperature Management, LLC
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
SIN SISTEMA DE IMPLANTE NACIONAL S.A
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Sklar Instruments
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Intuitive Surgical, Inc.
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
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
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Intuitive Surgical, Inc.
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
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Intuitive Surgical, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Abiomed, Inc.
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Intuitive Surgical, Inc.
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquade…
Nuwellis Inc
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK …
Cardinal Health 200, LLC
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
8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Intuitive Surgical, Inc.
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery c…
Alcon Research LLC
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
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Sklar Instruments
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
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
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Intuitive Surgical, Inc.
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
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Sklar Instruments
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
Change Healthcare Cardiology Hemo software
A L I Technologies Ltd
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
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
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.
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
Read our methodology — how this data is sourced, computed, and verified.