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 248 of 819
EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use wit…
Boston Scientific Corporation
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Heartware, Inc.
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Ortho-Clinical Diagnostics, Inc
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Luminex Corporation
Turbett Surgical Container, TS1500
TURBETT SURGICAL, LLC
Avanos Cortrak 2 Enteral Access System (EAS)
Avanos Medical, Inc.
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
Beckman Coulter Inc.
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law t…
Neuralynx Inc
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
CooperSurgical, Inc.
LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Smith & Nephew Inc
Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16B…
Total Resources Intl
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are d…
Medtronic Inc
Olympus Uretero-reno videoscope, Model No. URF-V2
Olympus Corporation of the Americas
EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use wi…
Boston Scientific Corporation
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
Beckman Coulter Inc.
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pac…
Windstone Medical Packaging, Inc.
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency cal…
Baxter Healthcare Corporation
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Abbott Vascular
MicroScan WalkAway-96 plus Instrument REF B1018-284
Beckman Coulter Inc.
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Karl Storz Endoscopy
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible …
Karl Storz Endoscopy
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Woodside Acquisitions Inc.
VITEK 2 Systems and VITEK 2 with MYLA.
bioMerieux, Inc.
BF-3C160: EVIS EXERA Bronchovideoscope
Olympus Corporation of the Americas
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
PROTERIXBIO
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm.…
Synthes (USA) Products LLC
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Olympus Corporation of the Americas
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular, Inc.
CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE, 15FR X 370MM, ADULT REF 11272C2 and Kit Number 11272CK2 CYSTO-URETHRO-FIBERSCOPE REF 11272CU…
Karl Storz Endoscopy
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-Urethroscope…
Karl Storz Endoscopy
HemosIL ReadiPlasTin, Part No. 0020301400
Instrumentation Laboratory
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Woodside Acquisitions Inc.
ACS Cath Lab Pack
American Contract Systems, Inc.
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US;…
Karl Storz Endoscopy
BF-MP60: OES Bronchofiberscope
Olympus Corporation of the Americas
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z…
Karl Storz Endoscopy
ACS Lap Chole Pack
American Contract Systems, Inc.
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-…
Ethicon, Inc.
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Olympus Corporation of the Americas
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
SIMPLIVIA HEALTHCARE LTD.
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodyna…
Philips North America Llc
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope (FLEX-XC) Z…
Karl Storz Endoscopy
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V …
Daavlin Distributing Company
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Karl Storz Endoscopy
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinu…
Certified Safety Mfg Inc
TMJ Arthroscopy Drape, 85''x 96''
Microtek Medical Inc.
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM0…
Medtronic Vascular, Inc.
Diagnostic Kit SARS-cCo V Antigen Rapid Test
USA Medical, LLC
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031U…
Karl Storz Endoscopy
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
American Contract Systems, 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.