2025 Recalls
6,236 federal recalls indexed for 2025 · Page 20 of 125
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, 43 moderate, and 0 lower-severity recalls. The page references 26 distinct recalling firms operating in 6 distinct product categories, with 46 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (28), CPSC (13), FDA Drug (5), 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.
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
Teva Pharmaceuticals USA, Inc
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01
Aero Healthcare
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Zydus Pharmaceuticals (USA) Inc
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Zydus Pharmaceuticals (USA) Inc
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
Zydus Pharmaceuticals (USA) Inc
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
Prismatik Dentalcraft, Inc.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Mozarc Medical US LLC
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Integra LifeSciences Corp. (NeuroSciences)
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Mozarc Medical US LLC
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
OSSTEM Implant Co., Ltd.
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Zimmer, Inc.
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Mozarc Medical US LLC
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Beckman Coulter, Inc.
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
OSSTEM Implant Co., Ltd.
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Zimmer, Inc.
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head; 3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head; 3205.47.028 Klassic BiPolar Head, 47 mm OD, 28 mm Head; 3205.48.028 Klassic BiPolar Head, 48 mm O
Total Joint Orthopedics, Inc.
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Mozarc Medical US LLC
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
OSSTEM Implant Co., Ltd.
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.
Spacelabs Healthcare, Ltd.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Mozarc Medical US LLC
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Mozarc Medical US LLC
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
Elekta, Inc.
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Integra LifeSciences Corp. (NeuroSciences)
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi,
Tandem Diabetes Care, Inc.
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Beckman Coulter, Inc.
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter Inc.
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Integra LifeSciences Corp. (NeuroSciences)
AUDI 2025: SEAT BELTS:FRONT:ANCHORAGE
AUDI
Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed R Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from ails; Sold on Amazon by Neaude
Ruiyewenhuachuanboshenzhenyouxiangongsi, dba Neaude, of China
Astemrey Recalls Y'all Can DIY Liquid Bioethanol Fireplace Fuel Containers Due to Risk of Serious Injury or Death from Flash Fire; Violates Mandatory Standard for Portable Fuel Containers
STARKIM KIMYA SAN.TIC. A.S, of Turkey
F&F Fine Wines Recalls Kirkland Signature Valdobbiadene Prosecco DOCG Bottles sold by Costco Due to Laceration Hazard
F&F Fine Wines Recalls Kirkland Signature Valdobbiadene Prosecco Entrapment or Suffocation; Violates Mandatory Standards for Mattresses; Sold on Amazon by Mengna Criblike Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment
Zhujisibeixuxinxizixunfuwubu dba Mengna, of China
Inkari Plush Alpaca Toys Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Violate Small Parts Ban; Imported by Inkari
Lezyne USA Recalls Bicycle Floor Pumps Due to Serious Injury Hazard
Napei Infant Bath Tubs Recalled Due to Risk of Serious Injury or Death from Ingestion Hazard; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Sefon Store
Sefon Store, of China
Peloton Recalls Original Series Bike+ Exercise Bikes Due to Fall and Injury Hazards
Sanven Technology Recalls Vevor Baby Swings Due to Risk of Serious Injury from Suffocation Hazard; Violates Mandatory Standard for Infant Sleep Products and Inclined Sleepers Ban
STIHL Recalls BR 800 Backpack Blowers Due to Laceration Hazard
STIHL Incorporated, of Virginia Beach, Virginia
Three-Wheeled Children's Scooters Recalled Due to Fall Hazard; Imported by Konges Sløjd
Umeyda Nightgowns Recalled Due to Risk of Serious Injury or Death from Burns; Violate Mandatory Standards for Children's Sleepwear; Sold on Amazon by Umeyda Company
Xindu District Miuwola Clothing Store dba Umeyda Company, of China
WYBITNY Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment; Violates Mandatory Standard for Children's Portable Bed Rails; Sold on Amazon by WYBITNY
Shanghai Siwu Jidan Shangmao Youxian Gongsi, dbaWYBITNY, of China
CHEVROLET 2020: SERVICE BRAKES, HYDRAULIC:POWER ASSIST
CHEVROLET
LEXUS,TOYOTA 2022-2024: ENGINE AND ENGINE COOLING:ENGINE:HARD PARTS INTERNAL/MECHANICAL
LEXUS,TOYOTA
JEEP 2023-2025: ENGINE
JEEP
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: 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.