Product category · Updated Jul 29, 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 (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 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 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- 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
40,910 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 · NHTSA federal recall filings · 2026-08-31
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 650 of 819
NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction catheter …
Halyard Health, Inc
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures…
Synthes (USA) Products LLC
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotom…
Synthes (USA) Products LLC
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to …
Sunrise Medical (US) LLC
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for perit…
Baxter Healthcare Corp.
Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Su…
Stryker Sustainability Solutions
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system,…
GE Healthcare
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03…
Nidek Inc
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and h…
PTW-Freiburg
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to pro…
Ethicon Endo-Surgery Inc
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantit…
Siemens Healthcare Diagnostics, Inc.
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in …
Philips Electronics North America Corporation
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
MRP, LLC dba AMUSA
Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
Tornier, Inc
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ra…
Carestream Health Inc
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Ream…
Trilliant Surgical Ltd.
MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis cathete…
Baxter Healthcare Corp.
Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infa…
Covidien LLC
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the T…
Trilliant Surgical Ltd.
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adu…
Medtronic MiniMed Inc.
Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infant…
Covidien LLC
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solutio…
Baxter Healthcare Corp.
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Ferno-Washington Inc
Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely fo…
Otto Bock Healthcare Product
cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitr…
Roche Diagnostics Operations, Inc.
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on …
Hardy Diagnostics
BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neur…
Becton, Dickinson and Company, BD Biosciences
LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to t…
Alcon Research, Ltd.
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility t…
Sunrise Medical (US) LLC
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications sy…
GE Healthcare
cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitr…
Roche Diagnostics Operations, Inc.
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for …
Trilliant Surgical Ltd.
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparati…
Omnilife Science Inc.
CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
Advanced Sterilization Products
Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 week…
Medline Industries Inc
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adap…
Baxter Healthcare Corp.
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, …
Arrow International Inc
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719…
Iris Diagnostics
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparat…
Omnilife Science Inc.
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatme…
RAYSEARCH LABORATORIES AB
Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
ASO, LLC
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular Syst…
Omnilife Science Inc.
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the tre…
Brainlab AG
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
Teleflex, Inc.
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended…
Teleflex Medical
Bronchial Double Lumen Tube Set (Right), Sterile
Teleflex, Inc.
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories wh…
Getinge Disinfection Ab
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
C.R. Bard, Inc.
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specifi…
Synthes (USA) Products LLC
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable…
International Biophysics Corp.
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 29, 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 29, 2026.