2025 Recalls
6,168 recalls · Page 98 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 7 critical, 43 moderate, and 0 lower-severity recalls. The page references 12 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), 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.
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information syst…
Merge Healthcare, Inc.
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
American Contract Systems Inc
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
American Contract Systems Inc
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 …
Oridion Medical 1987 Ltd.
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integr…
Merge Healthcare, Inc.
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
American Contract Systems Inc
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introd…
Smiths Medical ASD, Inc.
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
American Contract Systems Inc
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
American Contract Systems Inc
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
American Contract Systems Inc
CYSTO , Model No SACY80R
American Contract Systems Inc
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Car…
Merge Healthcare, Inc.
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
American Contract Systems Inc
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
American Contract Systems Inc
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
American Contract Systems Inc
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-…
Smiths Medical ASD, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information …
Merge Healthcare, Inc.
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in t…
Immuno-Mycologics, Inc
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introd…
Smiths Medical ASD, Inc.
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pedi…
Oridion Medical 1987 Ltd.
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Waldemar Link GmbH & Co. KG (Mfg Site)
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
American Contract Systems Inc
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - …
Oridion Medical 1987 Ltd.
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surg…
MEDLINE INDUSTRIES, LP - Northfield
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0…
Microbiologics Inc
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Smiths Medical ASD, Inc.
CYSTO PACK , Model N. HKCY31A
American Contract Systems Inc
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 11…
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
BORN ON ARRIVAL KIT , Model No LLBN11B
American Contract Systems Inc
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Smiths Medical ASD, Inc.
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
American Contract Systems Inc
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Waldemar Link GmbH & Co. KG (Mfg Site)
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
American Contract Systems Inc
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Smiths Medical ASD, Inc.
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
American Contract Systems Inc
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Brainlab AG
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Smiths Medical ASD, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Smiths Medical ASD, Inc.
AV FISTULA , Model No UTAV77T
American Contract Systems Inc
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Smiths Medical ASD, Inc.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Micros…
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - …
Oridion Medical 1987 Ltd.
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
American Contract Systems Inc
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Beckman Coulter, Inc.
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Deskt…
CareFusion 303, Inc.
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter, Inc.
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
American Contract Systems Inc
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
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.