Product category · Updated Aug 19, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
41,070 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-04
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 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 806 of 822
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Siemens Medical Solutions USA, Inc
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40C…
Applied Medical Resources Corp
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal …
Terumo Cardiovascular Systems Corporation
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for applicat…
Neomend Inc
Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATIO…
Applied Medical Resources Corp
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013…
Cordis Corporation
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device con…
Toshiba American Medical Systems Inc
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the …
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone …
Integra Limited
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Aler…
Alere San Diego, Inc.
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the periphe…
Micro Therapeutics Inc, Dba Ev3 Neurovascular
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
Mc-NEIL-PPC, Inc.
Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individual…
Invacare Corporation
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. …
KCI USA, Inc.
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured…
Varian Medical Systems, Inc. Oncology Systems
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforceme…
Covidien LP
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. Thes…
Alcon Research, LTD.
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, S…
Applied Medical Resources Corp
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
Linvatec Corp. dba ConMed Linvatec
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforceme…
Covidien LP
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone …
Integra Limited
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access…
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Cabot Recalls Wood Cleaner and Wood Brightener With Spray Pump Due To Irritation and Burn Hazard
Cabot Stains, a division of Valspar Corp., of Newburyport, Mass.
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for…
Instrumentation Laboratory Co.
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Custom Medical Specialties, Inc.
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically …
Instrumentation Laboratory Co.
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, …
Amsino Medical USA
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device i…
US Endoscopy Group Inc
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Lab…
Roche Molecular Systems, Inc.
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for i…
Instrumentation Laboratory Co.
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contain…
Custom Medical Specialties, Inc.
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Philips Healthcare Inc.
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET…
DePuy Orthopaedics, Inc.
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically …
Instrumentation Laboratory Co.
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Hospira Inc.
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Genera…
Covidien LLC
CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Custom Medical Specialties, Inc.
The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme im…
Bio-Rad Laboratories
Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorb…
Davol, Inc., Subs. C. R. Bard, Inc.
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Custom Medical Specialties, Inc.
Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes inte…
Kimberly-Clark Corporation
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in…
Instrumentation Laboratory Co.
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring…
Zoe Medical Incorporated
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 006496…
Siemens Healthcare Diagnostics, Inc
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray syst…
Philips Medical Systems (Cleveland) Inc
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
Custom Medical Specialties, Inc.
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional…
Philips Medical Systems (Cleveland) Inc
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Asahi Kasei Medical Co., Ltd., Okatomi Plant
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1 . To determine if the version you are using is affected, …
RAYSEARCH LABORATORIES AB
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 Aug 19, 2026.
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. 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 Aug 19, 2026.