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 406 of 819
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Teleflex Medical
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 4…
Datascope Corporation
Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
Olympus Corporation of the Americas
Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
Pharmaceutical Innovations, Inc.
BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDT…
Becton Dickinson & Company
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6,…
Philips North America, LLC
Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray …
Canon Medical System, USA, INC.
Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage c…
Rinovum Women's Health
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005…
COVIDIEN LLC
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult…
Hamilton Medical AG
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, …
Becton Dickinson & Company
Cios care fusion system
Siemens Medical Solutions USA, Inc
Cios Alpha VA20/ VA30 mobile X-Ray systems
Siemens Medical Solutions USA, Inc
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate base…
GE Healthcare, LLC
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate ba…
GE Healthcare, LLC
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Helena Laboratories, Corp.
Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product …
Applied Medical Resources Corp
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packa…
Richard Wolf Medical Instruments Corp.
ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Helena Laboratories, Corp.
Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 6…
PharMEDium Services, LLC
Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver …
InvaGen Pharmaceuticals, Inc.
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intende…
Siemens Medical Solutions USA, Inc
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal fai…
Baxter Healthcare Corporation
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantati…
Zimmer Biomet, Inc.
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is …
Siemens Medical Solutions USA, Inc
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kina…
Siemens Healthcare Diagnostics, Inc.
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantatio…
Zimmer Biomet, Inc.
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN O…
Medtronic Navigation, Inc.-Littleton
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthope…
Zimmer Biomet, Inc.
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or …
ZOLL Medical Corporation
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Siemens Medical Solutions USA, Inc
SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is …
Siemens Medical Solutions USA, Inc
Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Siemens Medical Solutions USA, Inc
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) .…
RAYSEARCH LABORATORIES AB
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, I…
Beckman Coulter Inc.
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Bio-Rad Laboratories, Inc
Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Siemens Medical Solutions USA, Inc
Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Siemens Medical Solutions USA, Inc
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is inte…
Siemens Medical Solutions USA, Inc
Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
Siemens Medical Solutions USA, Inc
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and …
Ortho-Clinical Diagnostics
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare informat…
GE Healthcare, LLC
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Bio-Detek, Inc.
Powerheart¿ G5 Automatic AED
Cardiac Science Corporation
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid…
Phadia Ab
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is inten…
Siemens Medical Solutions USA, Inc
Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
Siemens Medical Solutions USA, Inc
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Siemens Medical Solutions USA, Inc
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and …
Ortho-Clinical Diagnostics
Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem im…
Philips Medical Systems (Cleveland) 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.