PlainRecalls

2025 Recalls

6,168 recalls · Page 84 of 124

2025 Recall Year Insight

Federal agencies issued 6,168 product recalls indexed by PlainRecalls in calendar year 2025. That represents about 6.06% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 16.9 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 124 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 22 critical, 28 moderate, and 0 lower-severity recalls. The page references 22 distinct recalling firms operating in 5 distinct product categories, with 36 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (28), NHTSA (14), FDA Drug (6), 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 Moderate May 14, 2025

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, …

BRS Analytical Services, LLC

FDA Drug Moderate May 14, 2025

TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only,…

BSO LLC

FDA Drug Moderate May 14, 2025

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Ste…

BRS Analytical Services, LLC

FDA Drug Moderate May 14, 2025

TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use…

BSO LLC

FDA Drug Moderate May 14, 2025

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Steril…

BRS Analytical Services, LLC

FDA Drug Moderate May 14, 2025

TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only,…

BSO LLC

FDA Devices Moderate May 14, 2025

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Ped…

Philips North America Llc

FDA Devices Critical May 14, 2025

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PU…

Smiths Medical ASD, Inc.

FDA Devices Moderate May 14, 2025

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Philips Medical Systems Nederland B.V.

FDA Devices Moderate May 14, 2025

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Remote Diagnostic Technologies Ltd.

FDA Devices Moderate May 14, 2025

Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation insti…

WANDERCRAFT SAS

FDA Devices Critical May 14, 2025

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21…

Smiths Medical ASD, Inc.

FDA Devices Moderate May 14, 2025

GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other intervent…

Galt Medical Corporation

FDA Devices Critical May 14, 2025

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Critical May 14, 2025

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-…

Smiths Medical ASD, Inc.

FDA Devices Moderate May 14, 2025

B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introd…

Galt Medical Corporation

FDA Devices Critical May 14, 2025

CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CAD…

Smiths Medical ASD, Inc.

FDA Devices Moderate May 14, 2025

INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate May 14, 2025

Artix MT Thrombectomy Device, REF: 32-102

Inari Medical - Oak Canyon

FDA Devices Moderate May 14, 2025

Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical May 14, 2025

CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated…

Smiths Medical ASD, Inc.

FDA Devices Moderate May 14, 2025

Washer Disinfector Aquadis 56; Model Number: 56M

Getinge Disinfection Ab

FDA Devices Moderate May 14, 2025

B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indica…

Galt Medical Corporation

FDA Devices Moderate May 14, 2025

Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

SCIENCE & BIO MATERIALS

FDA Devices Moderate May 14, 2025

Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

Tornier S.A.S.

FDA Devices Critical May 14, 2025

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Bausch & Lomb Surgical, Inc.

FDA Devices Moderate May 14, 2025

Washer Disinfector Aquadis 56; Model Number: 56A

Getinge Disinfection Ab

FDA Devices Moderate May 14, 2025

Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to …

Galt Medical Corporation

FDA Devices Moderate May 14, 2025

Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

Galt Medical Corporation

FDA Devices Critical May 14, 2025

CODMAN Disposable Perforator, 14mm. Cranial perforator.

Integra LifeSciences Corp. (NeuroSciences)

FDA Devices Moderate May 14, 2025

Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553…

Galt Medical Corporation

FDA Devices Critical May 14, 2025

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL,…

Bausch & Lomb Surgical, Inc.

FDA Devices Moderate May 14, 2025

Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

Ambu Inc.

FDA Devices Moderate May 14, 2025

GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage pr…

Galt Medical Corporation

NHTSA Critical May 14, 2025

FORD,LINCOLN 2021-2025: BACK OVER PREVENTION:SOFTWARE

FORD,LINCOLN

NHTSA Critical May 14, 2025

FORD 2022-2023: BACK OVER PREVENTION: SENSING SYSTEM: CAMERA

FORD

NHTSA Critical May 13, 2025

ALFA ROMEO,DODGE 2023-2024: BACK OVER PREVENTION: SENSING SYSTEM: CAMERA

ALFA ROMEO,DODGE

NHTSA Critical May 12, 2025

MERCEDES-BENZ 2023-2024: ELECTRICAL SYSTEM:WIRING:FUSES AND CIRCUIT BREAKERS

MERCEDES-BENZ

NHTSA Critical May 9, 2025

FORD,LINCOLN 2025: STRUCTURE:FRAME AND MEMBERS

FORD,LINCOLN

NHTSA Critical May 9, 2025

FORD,LINCOLN 2022-2024: SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS

FORD,LINCOLN

NHTSA Critical May 9, 2025

FORD 2022-2023: ELECTRONIC STABILITY CONTROL (ESC)

FORD

NHTSA Critical May 9, 2025

FORD 2021-2022: BACK OVER PREVENTION: SENSING SYSTEM: CAMERA

FORD

NHTSA Critical May 9, 2025

FORD 2025: SEATS:CRITICAL FASTENERS

FORD

NHTSA Critical May 9, 2025

FORD 2024-2025: SUSPENSION:FRONT:CONTROL ARM:UPPER BALL JOINT

FORD

NHTSA Critical May 9, 2025

FORD 2025: STEERING

FORD

NHTSA Critical May 9, 2025

FORD 2024-2025: SUSPENSION:FRONT:CONTROL ARM:LOWER ARM

FORD

NHTSA Critical May 9, 2025

FORD 2025: FUEL SYSTEM, DIESEL:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS

FORD

NHTSA Moderate May 9, 2025

FORD 2024: LATCHES/LOCKS/LINKAGES:DOORS:LOCK

FORD

CPSC Moderate May 8, 2025

Delta Gas Ball Valves Recalled Due to Fire and Burn Hazards; Manufactured by Masco Canada

Masco Canada Limited, of Canada

CPSC Moderate May 8, 2025

DEMDACO Recalls Maril Brand Scented Candles Due to Laceration and Fire Hazards

DEMDACO, of Leawood, Kansas

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2025 across the FDA, CPSC 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 August 2026.