Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 113 of 808
Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalm…
Alcon Research LLC
Alinity hq Analyzer, REF: 09P68-01
Abbott Laboratories
Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Descr…
Alcon Research LLC
Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife C…
Alcon Research LLC
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmi…
Alcon Research LLC
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
MEDLINE INDUSTRIES, LP - Northfield
Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
Alcon Research LLC
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d…
MEDLINE INDUSTRIES, LP - Northfield
Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Op…
Alcon Research LLC
Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Op…
Alcon Research LLC
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
Alcon Research LLC
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d…
MEDLINE INDUSTRIES, LP - Northfield
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System …
Alcon Research LLC
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
Alcon Research LLC
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
MEDLINE INDUSTRIES, LP - Northfield
Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
Alcon Research LLC
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed steri…
Alcon Research LLC
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophtha…
Alcon Research LLC
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-…
Inari Medical - Oak Canyon
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible W…
Preat Corp
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) E…
MEDLINE INDUSTRIES, LP - Northfield
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
BioFire Diagnostics, LLC
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Microtek Medical Inc.
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
MEDLINE INDUSTRIES, LP - Northfield
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) …
Becton Dickinson & Co.
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (S…
Baxter Healthcare Corporation
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Covidien
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Op…
Alcon Research LLC
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other …
Ion Beam Applications S.A.
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
Alcon Research LLC
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
Alcon Research LLC
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
MEDLINE INDUSTRIES, LP - Northfield
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 35…
Baxter Healthcare Corporation
Regard Kit containing the Microtek decanter
ROi CPS LLC
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
MEDLINE INDUSTRIES, LP - Northfield
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated …
Ortho-Clinical Diagnostics, Inc.
1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d)…
MEDLINE INDUSTRIES, LP - Northfield
Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Descrip…
Alcon Research LLC
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
Covidien
Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
Alcon Research LLC
Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
Alcon Research LLC
Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A…
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371…
MEDLINE INDUSTRIES, LP - Northfield
Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
Alcon Research LLC
Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic…
Alcon Research LLC
1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
MEDLINE INDUSTRIES, LP - Northfield
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 2, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 2, 2026.