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.
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
IsoTis OrthoBiologics, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 471405
Intuitive Surgical, Inc.
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.
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Sklar Instruments
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo…
Augustine Temperature Management, LLC
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Intuitive Surgical, Inc.
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
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Intuitive Surgical, Inc.
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
Change Healthcare Cardiology Hemodynamics software
A L I Technologies Ltd
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
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
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
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Intuitive Surgical, Inc.
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
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Sklar Instruments
8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 470405
Intuitive Surgical, Inc.
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Tornier S.A.S.
8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Intuitive Surgical, Inc.
8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Intuitive Surgical, Inc.
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
8MM, POTTS SCISSORS, IS4000 REF 470001
Intuitive Surgical, Inc.
8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Intuitive Surgical, Inc.
8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Intuitive Surgical, Inc.
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
Sklar Instruments
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Boston Scientific Corporation
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
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA…
Coloplast Manufacturing US, LLC
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNG…
Cardinal Health 200, LLC
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
Sklar Instruments
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71…
Augustine Temperature Management, LLC
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
Sklar Instruments
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
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
Trokamed GmbH
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
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Baxter Healthcare Corporation
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Intuitive Surgical, Inc.
Impella RP with SmartAssist; Product Number: 0046-0035;
Abiomed, Inc.
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
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Boston Scientific Corporation
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
8MM,COBRA GRASPER,IS4000 REF 471190
Intuitive Surgical, Inc.
8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Intuitive Surgical, Inc.
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
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
8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Intuitive Surgical, Inc.
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.
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.