FDA Medical Devices
All recall actions attributed to FDA Medical Devices in our federal database. Each record links back to the agency's official notice so you can verify status, remedy, and amendments before acting.
U.S. Food and Drug Administration — Medical device recalls
39,794 recalls · Page 94 of 796
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FDA Medical Devices Recall Insight
According to PlainRecalls' agency ranking (distinct recall events, same sort as /agency), FDA Medical Devices sits #1 of 6 (1st among 6 issuing agencies) with 39,794 notices, about 38.1% of the 104,423-record archive. The agency's stated scope - U.S. Food and Drug Administration — Medical device recalls - determines what classes of products flow through its recall pipeline and how quickly notices reach consumers. With 796 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.
Looking at the 50 records on this page alone, the severity distribution skews toward 6 critical (Class I-equivalent) actions, 44 moderate recalls, and 0 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 50 disclose a unit count, the gap reflects regulatory filing norms where firms disclose lot numbers or distribution channels instead of absolute quantities. This page spans recalls from Jan 22, 2025 to Jan 22, 2025, covering 17 distinct firms. Severity mix is a leading indicator: a page weighted toward critical classifications usually signals an active public-health concern, while lower-severity clusters often represent labeling, undeclared-allergen, or minor design corrections.
Agency-level browsing is useful when a defect pattern crosses categories, for example, a supplier contamination can trigger dozens of downstream recalls that share no obvious product tag but a single issuing agency. Use the pagination below to scan the full archive, or combine this agency filter with category and manufacturer views elsewhere on PlainRecalls to intersect the data. Recall records are sourced directly from FDA Medical Devices's public enforcement feeds and are updated as the agency publishes new notices; the federal record is the authoritative version, and this page aggregates what the agency itself has released. For high-stakes decisions, medical, automotive, or childcare, always click through to the recall detail page and cross-verify the recall number against the agency's current site. Record counts reflect all indexed actions regardless of status (ongoing, terminated, or completed).
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Intuitive Surgical, Inc.
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Intuitive Surgical, Inc.
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECT
Cardinal Health 200, LLC
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Baxter Healthcare Corporation
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractor
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPE
Sklar Instruments
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 1
ev3 Inc
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose
QUIDEL ORTHO
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Cook Biotech, Inc.
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913; 7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914; 8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951; 9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952; 10)
Cardinal Health 200, LLC
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Cook Biotech, Inc.
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Boston Scientific Corporation
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
Sklar Instruments
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
CareFusion 303, Inc.
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Intuitive Surgical, Inc.
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 surgical tasks including manipulation and retraction of tissue.
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), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
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, 1050839, 1050840, 1050841, 1050842
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 NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures
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 HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous procedures
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 STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
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) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
Coloplast Manufacturing US, LLC
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ; 5 ) STERILE LARYNGOSCOPY PACK, Catalog Number: SEN11LGUHB
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) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
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
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Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Consult a qualified professional before making decisions based on this data.
- Source: FDA Medical Devices - verify with the issuing agency: official recall page →
- Source: PlainRecalls Data Index - aggregated from FDA openFDA, CPSC, USDA FSIS, and NHTSA public databases
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Recall counts and figures reflect FDA Medical Devices's own published filings, aggregated alongside the other two federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.