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
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 383 of 819
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
Valeritas, Incorporated
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Valeritas, Incorporated
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
LABSTYLE INNOVATIONS
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: p…
Stryker Neurovascular
Various products which were contract sterilized.
Anewmed Corporation
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic sur…
Intuitive Surgical, Inc.
Kit, Port Access Product Code: DYNDC1582A
Centurion Medical Products Corporation
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
Alto Development Corp
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is inten…
Mindray DS USA, Inc. dba Mindray North America
Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is int…
Stryker Neurovascular
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: p…
Stryker Neurovascular
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Ethicon Endo-Surgery Inc
SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/…
Pajunk GmbH
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
Valeritas, Incorporated
Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3…
ConvaTec, Inc
A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
Alto Development Corp
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
Ethicon Endo-Surgery Inc
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in th…
Hycor Biomedical LLC
SAROS Oxygen System Model 3000
Caire, Inc.
CardioLab/ComboLab Recording Systems
GE Healthcare, LLC
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
Valeritas, Incorporated
A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
Alto Development Corp
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Synthes (USA) Products LLC
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumpin…
Thoratec Switzerland GMBH
Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is inten…
Stryker Neurovascular
Port full Access Tray Product Code: DT19330
Centurion Medical Products Corporation
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Senseonics, Inc.
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: pro…
Stryker Neurovascular
Posey Connected Twice-As-Tough Cuffs
TIDI PRODUCTS
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Draegar Medical Systems, Inc.
Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is …
Mindray DS USA, Inc. dba Mindray North America
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Cordis Corporation
SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independ…
LivaNova USA Inc.
A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
Alto Development Corp
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonl…
OrthoPediatrics Corp
Skacel Collection Recalls FlipStix Knitting Needles Due to Laceration Hazard
Gustav Selter GmbH Co. & KG, of Germany
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800…
Life Technologies Holdings Pte Ltd
Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
Candela Corporation
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Siemens Healthcare Diagnostics, Inc.
BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide…
Becton Dickinson & Company
The ICS CHARTR EP 200
GN Otometrics
Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
Candela Corporation
Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Siemens Healthcare Diagnostics, Inc.
IMRIS MR/X-ray head fixation device, Model HFD200
Deerfield Imaging, Inc.
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3.…
Baxter Healthcare Corporation
Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
Andover Healthcare Inc.
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 2…
Smiths Medical ASD Inc.
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by S…
Xintec 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.