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 199 of 819
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
SD Biosensor, Inc.
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
PHILIPS HEADQUARTERS CAMBRIDGE
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal …
Olympus Corporation of the Americas
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemog…
Ortho-Clinical Diagnostics, Inc.
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial…
Olympus Corporation of the Americas
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Windstone Medical Packaging, Inc.
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, …
Siemens Healthcare Diagnostics, Inc.
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
PHILIPS HEADQUARTERS CAMBRIDGE
Luminos dRF Max (VE10, VF10, VF11)
Siemens Medical Solutions USA, Inc
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
PHILIPS HEADQUARTERS CAMBRIDGE
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
OmniCell, Inc.
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salic…
Siemens Healthcare Diagnostics, Inc.
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
PHILIPS HEADQUARTERS CAMBRIDGE
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
Olympus Corporation of the Americas
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrosp…
Integra LifeSciences Corp.
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Windstone Medical Packaging, Inc.
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Windstone Medical Packaging, Inc.
Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
Arjohuntleigh Magog, Inc.
LUMINOS Lotus Max (VF11)
Siemens Medical Solutions USA, Inc
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Binx Health, Inc.
FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
Apollo Care, LLC
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Stryker Sustainability Solutions
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Beckman Coulter, Inc.
VentStar Basic (P)180, MP00351
Draeger Medical, Inc.
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
ICU Medical Inc
3M Attest Steam Chemical Integrators, REF 1243B
3M Company - Health Care Business
ASM Replacement Battery, Component Number SUB0000864
ICU Medical Inc
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Boston Scientific Corporation
Set2Go Ventilation 12 (A), MP07968
Draeger Medical, Inc.
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Boston Scientific Corporation
Seattle PAP Plus, MP02260
Draeger Medical, Inc.
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Surgical Innovations Ltd
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-v…
Beckman Coulter, Inc.
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Smiths Medical ASD Inc.
VentStar Anesthesia WT (P)180, MP00374
Draeger Medical, Inc.
Anesthesia Set Coax 180, MP03384
Draeger Medical, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 100021…
Abiomed, Inc.
ProxiDiagnost N90 R.1.0
Philips North America
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Beckman Coulter, Inc.
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Beckman Coulter Inc.
CombiDiagnost R90 R.1.0
Philips North America
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Access Vascular, Inc
VentStar Watertrap (N) 180, MP00363
Draeger Medical, Inc.
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites …
TELEFLEX LLC
VentStar Watertrap (P) 180, MP00361
Draeger Medical, Inc.
VentStar Anesthesia (N) 180, MP00333
Draeger Medical, Inc.
Ventstar Coax, MP03373
Draeger Medical, Inc.
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/…
IMMUNDIAGNOSTIK, Inc
ID Circuit Basic (P) 180, MP01340
Draeger Medical, Inc.
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Beckman Coulter 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 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.