PlainRecalls

2025 Recalls

Compiled from official public sources by the editorial team.

6,168 recalls · Page 31 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 20 critical, 30 moderate, and 0 lower-severity recalls. The page references 14 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.

FDA Devices Critical Oct 22, 2025

Model Number L121 ESSENTIO DR EL Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

GE Medical Systems, LLC

FDA Devices Moderate Oct 22, 2025

Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROS…

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

Model Number L110, ESSENTIO SR SL MRI Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Prod…

Baxter Healthcare Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the m…

Insulet Corporation

FDA Devices Critical Oct 22, 2025

Model Number U225 VISIONIST CRT-P EL

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-in…

Baxter Healthcare Corporation

FDA Devices Critical Oct 22, 2025

Model Number L210 PROPONENT SR SL Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

Medical convenience kits UDPG88W PICC G-TUBE PACK-230209

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Pro…

Spacelabs Healthcare, Inc.

FDA Devices Moderate Oct 22, 2025

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC …

BioPro, Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDI…

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

ACCOLADE DR SL (Model L301)

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEM…

BioPro, Inc.

FDA Devices Moderate Oct 22, 2025

XERF EFFECTOR 60. Electrosurgical unit.

Lutronic Corporation

FDA Devices Critical Oct 22, 2025

ACCOLADE DR EL (Model L321)

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Olympus Corporation of the Americas

FDA Devices Critical Oct 22, 2025

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

Abbott

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INT…

American Contract Systems Inc.

FDA Devices Moderate Oct 22, 2025

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72…

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

Model Number S701 ALTRUA 2 SR SL Pacemaker

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

Model Number L111, ESSENTIO DR SL MRI Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

LOGIQ P10 series with software version R4.5.7 Model Number 5877534

GE Medical Systems, LLC

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW…

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

Olympus Corporation of the Americas

FDA Devices Critical Oct 22, 2025

ACCOLADE SR SL (Model L300)

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra …

ConvaTec, Inc

FDA Devices Critical Oct 22, 2025

Model Number U125, VALITUDE CRT-P EL

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72…

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code…

Baxter Healthcare Corporation

FDA Devices Moderate Oct 22, 2025

Medline Adult Anesthesia Set, REF DYNJ39985G

Medline Industries, LP

FDA Devices Moderate Oct 22, 2025

Cardiac Workstation 7000; Model Number: 860441;

Philips North America

FDA Devices Moderate Oct 22, 2025

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, …

Contego Medical LLC

FDA Devices Moderate Oct 22, 2025

BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10…

BioPro, Inc.

FDA Devices Critical Oct 22, 2025

Model Number L100, ESSENTIO SR SL Pacemaker

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFL…

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951

American Contract Systems Inc.

FDA Devices Critical Oct 22, 2025

ACCOLADE SR SL MRI (Model L310)

Boston Scientific Corporation

FDA Devices Critical Oct 22, 2025

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

Olympus Corporation of the Americas

FDA Devices Moderate Oct 22, 2025

CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 724…

Boston Scientific Corporation

FDA Devices Moderate Oct 22, 2025

BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HE…

BioPro, Inc.

FDA Devices Moderate Oct 22, 2025

Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT

American Contract Systems Inc.

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 July 2026.