PlainRecalls

2025 Recalls

6,168 recalls · Page 118 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 9 critical, 41 moderate, and 0 lower-severity recalls. The page references 15 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 Moderate Jan 22, 2025

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

IsoTis OrthoBiologics, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,FORCE BIPOLAR,IS4000 REF 471405

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of …

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M

Sklar Instruments

FDA Devices Critical Jan 22, 2025

Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

FDA Devices Moderate Jan 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo…

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 10508…

Mercury Enterprises, Inc. dba Mercury Medical

FDA Devices Moderate Jan 22, 2025

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS N…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Change Healthcare Cardiology Hemodynamics software

A L I Technologies Ltd

FDA Devices Moderate Jan 22, 2025

GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Critical Jan 22, 2025

ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)

Boston Scientific Corporation

FDA Devices Moderate Jan 22, 2025

8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HO…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,FORCE BIPOLAR,IS4000 REF 470405

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

Tornier S.A.S.

FDA Devices Moderate Jan 22, 2025

8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERIL…

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

8MM, POTTS SCISSORS, IS4000 REF 470001

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Critical Jan 22, 2025

VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

Boston Scientific Corporation

FDA Devices Moderate Jan 22, 2025

GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) …

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA…

Coloplast Manufacturing US, LLC

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNG…

Cardinal Health 200, LLC

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71…

Augustine Temperature Management, LLC

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A

Sklar Instruments

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBA…

Sklar Instruments

FDA Devices Critical Jan 22, 2025

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

FDA Devices Moderate Jan 22, 2025

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL B…

Sklar Instruments

FDA Devices Critical Jan 22, 2025

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Baxter Healthcare Corporation

FDA Devices Moderate Jan 22, 2025

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296

Intuitive Surgical, Inc.

FDA Devices Critical Jan 22, 2025

Impella RP with SmartAssist; Product Number: 0046-0035;

Abiomed, Inc.

FDA Devices Moderate Jan 22, 2025

Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP …

Cardinal Health 200, LLC

FDA Devices Critical Jan 22, 2025

ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

Boston Scientific Corporation

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography…

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Moderate Jan 22, 2025

8MM,COBRA GRASPER,IS4000 REF 471190

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, …

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Devices Critical Jan 22, 2025

Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jan 22, 2025

8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347

Intuitive Surgical, Inc.

FDA Devices Moderate Jan 22, 2025

8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249

Intuitive Surgical, 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 August 2026.