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 326 of 819
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeuti…
Stimwave Technologies Inc
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
RANDOX LABORATORIES, LTD.
Parvovirus B19 IgG EIA kit Part No. V519IGUS
Diasorin Inc.
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Exactech, Inc.
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic…
Stimwave Technologies Inc
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimul…
Stimwave Technologies Inc
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac trop…
Siemens Healthcare Diagnostics, Inc.
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antise…
Remel Europe Ltd.
Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheteriza…
Siemens Medical Solutions USA, Inc
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
Brainlab AG
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulati…
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulatio…
Stimwave Technologies Inc
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional i…
CareFusion 303, Inc.
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic…
Stimwave Technologies Inc
Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter is indicated to be used in any surgical procedure requiring attachment t…
TELEFLEX MEDICAL INC
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent
RANDOX LABORATORIES, LTD.
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic …
Cardinal Health 200, LLC
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection…
C.A. Greiner & Sohne Gesellschaftmbh
WHILL Recalls WHILL Personal Electric Vehicles Due to Crash and Injury Hazards
WHILL, Inc. (Japan), of Japan
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0…
Datascope Corporation
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visual…
Karl Storz Endoscopy
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and v…
Karl Storz Endoscopy
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: …
Neurovision Medical Products Inc
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Globus Medical, Inc.
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and sta…
Neurovision Medical Products Inc
Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of…
Siemens Medical Solutions USA, Inc
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac …
Datascope Corporation
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Prod…
Ortho-Clinical Diagnostics
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electroph…
Biosense Webster (israel), Ltd.
VITROS XT7600 Integrated System, Product code 6844461
Ortho Clinical Diagnostics
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Globus Medical, Inc.
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acu…
Datascope Corporation
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Globus Medical, Inc.
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-0…
Datascope Corporation
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, usin…
Siemens Medical Solutions USA, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Globus Medical, Inc.
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring a…
Neurovision Medical Products Inc
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visual…
Karl Storz Endoscopy
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-…
Datascope Corporation
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring …
Neurovision Medical Products Inc
VITROS XT3400 Chemistry System, Product code 6844458
Ortho Clinical Diagnostics
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02…
Datascope Corporation
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.