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 249 of 819
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare Co., Ltd.
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
American Contract Systems, Inc.
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
Karl Storz Endoscopy
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
Karl Storz Endoscopy
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Cerapedics, Inc.
Regard brand CABG Pack A and B - Spartanburg
ROi CPS LLC
Accula SARS-CoV-2 Test, REF: COV4100
MESA BIOTECH, INC
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 112…
Karl Storz Endoscopy
4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60H…
Daavlin Distributing Company
ACS IR - Angio Pack
American Contract Systems, Inc.
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary…
Baxter Healthcare Corporation
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Siemens Healthcare Diagnostics, Inc.
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Johnson & Johnson Surgical Vision Inc
K-Wire, 1.35 mm x 170 mm
Arthrex, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Siemens Healthcare Diagnostics, Inc.
Restrata, Part Number RWM1-2X2
Acera Surgical Inc
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
restor3d Inc.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Siemens Healthcare Diagnostics, Inc.
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Olympus Corporation of the Americas
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Becton Dickinson & Co.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
DePuy Orthopaedics, Inc.
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical in…
restor3d Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
restor3d Inc.
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Siemens Healthcare Diagnostics, Inc.
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
SML Distribution, LLC
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
ASO LLC
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Siemens Healthcare Diagnostics, Inc.
Azurion systems with software release R1.x
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 …
Intuitive Surgical, Inc.
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Freudenberg Medical, Llc
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during rad…
Boston Scientific Corporation
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Siemens Medical Solutions USA, Inc.
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for p…
Boston Scientific Corporation
Smart Toe II Intramedullary Arthrodesis Implant
Stryker GmbH
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother;…
ROi CPS LLC
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Draegar Medical Systems, Inc.
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Siemens Healthcare Diagnostics, Inc.
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upg…
Siemens Medical Solutions USA, Inc
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Carl Zeiss Meditec AG
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade …
Siemens Medical Solutions USA, Inc
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
ROi CPS LLC
Puritan Bennett 980 Series Ventilator
Medtronic formerly Covidien
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3…
Instrumentation Laboratory
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Baxter Healthcare Corporation
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Freudenberg Medical, Llc
PrisMax System, Product Code 955724
Baxter Healthcare Corporation
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) T…
Medtronic Neuromodulation
WAVES WCM Kidney Cassette Module
Waters Medical Systems LLC
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.