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 16 of 808
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument…
Olympus Corporation of the Americas
Impella RP with SmartAssist. Product Code: 0046-0035.
Abiomed, Inc.
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Descri…
Olympus Corporation of the Americas
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed …
B Braun Medical Inc
Impella RP. Product Code: 0046-0011.
Abiomed, Inc.
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Staar Surgical AG
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description…
Aesculap Inc
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
ESAOTE S.P.A.
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, materi…
Roche Diagnostics Operations, Inc.
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Rad…
GE Healthcare
CS300 IABP. Software Version CS300 IABP C.01.
Datascope Corp.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Siemens Healthcare Diagnostics, Inc.
CS100 IABP. Software Version CS100 IABP Q.01.
Datascope Corp.
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A devi…
B Braun Medical Inc
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A…
B Braun Medical Inc
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR …
Olympus Corporation of the Americas
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - …
Diagnostica Stago, Inc.
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, …
Vascutek, Ltd.
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog…
Olympus Corporation of the Americas
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Advanced Bionics, LLC
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S …
Olympus Corporation of the Americas
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Medline Industries, LP
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Medline Industries, LP
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Encore Medical, LP
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
MRIMed Inc.
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Olympus Corporation of the Americas
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT1981…
Medline Industries, LP
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Medtronic Perfusion Systems
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Medline Industries, LP
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Medline Industries, LP
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 …
Medline Industries, LP
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Olympus Corporation of the Americas
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Encore Medical, LP
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Olympus Corporation of the Americas
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Olympus Corporation of the Americas
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, M…
Medline Industries, LP
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Edermy LLC
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
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.