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 812 of 822
TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS,…
Tango3 LLC
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Radiometer America Inc
Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributo…
Medical Specialties Distributors, Inc.
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, …
Terumo Cardiovascular Systems Corporation
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatin…
Abbott Point Of Care Inc.
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood f…
Radiometer America Inc
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: int…
Smith & Nephew, Inc. Endoscopy Division
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chr…
Impact Instrumentation, Inc.
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT s…
Linvatec Corp. dba ConMed Linvatec
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Apheresis Technologies, Inc.
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Philips Healthcare Inc.
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Encore Medical, Lp
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the para…
Radiometer America Inc
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
Berchtold Corp.
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro di…
Siemens Healthcare Diagnostics, Inc.
i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardia…
Abbott Point Of Care Inc.
Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implant…
Straumann USA, LLC
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog N…
Angiodynamics Worldwide Headquarters
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical procedures …
Transenterix, Inc
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Trans…
Kimberly-Clark Corporation
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for…
Smith & Nephew, Inc. Endoscopy Division
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for…
Siemens Healthcare Diagnostics, Inc.
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Pro…
Varian Medical Systems, Inc. Oncology Systems
Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the su…
Stryker Spine
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Exactech, Inc.
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
ICU Medical, Inc.
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixa…
Integra LifeSciences Corp.
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas o…
Beekley Corporation
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
ICU Medical, Inc.
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamin…
Intuitive Surgical, Inc.
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Exactech, Inc.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, pota…
Abbott Point Of Care Inc.
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamin…
Intuitive Surgical, Inc.
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general…
GE OEC Medical Systems, Inc
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Exactech, Inc.
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Exactech, Inc.
Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to …
Maquet Medical Systems, Usa
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC mat…
Iris Diagnostics
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Exactech, Inc.
Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or area…
Beekley Corporation
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and…
Intuitive Surgical, Inc.
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. …
Church & Dwight Inc
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product U…
Sunrise Medical (US) LLC
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contami…
Intuitive Surgical, Inc.
RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination wit…
Stryker Instruments Div. of Stryker Corporation
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or area…
Beekley Corporation
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08…
Church & Dwight Inc
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput b…
Perkinelmer
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 U…
Church & Dwight Inc
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument…
Zimmer Inc.
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.