Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 155 of 808
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Encore Medical, LP
STERILE PVP SOLUTION, REF DYNDA1907
MEDLINE INDUSTRIES, LP - Northfield
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-52…
Riverpoint Medical, LLC
Medline Leg bag, REF URO12573
MEDLINE INDUSTRIES, LP - Northfield
STERILE POVIDONE, REF DYNDA2061
MEDLINE INDUSTRIES, LP - Northfield
Medline Leg bag, REF DYND12574
MEDLINE INDUSTRIES, LP - Northfield
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray gen…
GE Hangwei Medical Systems, Co. LTD
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Sy…
Philips North America Llc
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
CHANGE HEALTHCARE CANADA COMPANY
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
STERILE BETADINE, REF DYNDA1998
MEDLINE INDUSTRIES, LP - Northfield
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing int…
Meridian Bioscience Inc
TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Olympus Corporation of the Americas
Navik 3D v2, REF NAVIK3D, 3D Mapping System
APN Health LLC
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites C…
Meridian Bioscience Inc
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Baxter Healthcare Corporation
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Limacorporate S.p.A
Medline Leg bag, REF DYND12578
MEDLINE INDUSTRIES, LP - Northfield
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass ci…
Maquet Medical Systems USA
STERILE PVP, REF DYNDA1649
MEDLINE INDUSTRIES, LP - Northfield
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen…
BioReference Health, LLC
STERILE STERILE PREP STICK, REF DYNDA1134
MEDLINE INDUSTRIES, LP - Northfield
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray gen…
GE Hangwei Medical Systems, Co. LTD
Medtronic SynchroMed, Model A10
Medtronic Inc.
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Bebig Isotopentechnik Gmbh
STERILE PVP SLN KIT, REF DYNDM1097
MEDLINE INDUSTRIES, LP - Northfield
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/8…
Integra LifeSciences Corp.
Sensica Urine Output System, Catalog Number SCCS1002
C.R. Bard Inc
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Num…
Meridian Bioscience Inc
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Siemens Medical Solutions USA, Inc
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Ortho-Clinical Diagnostics, Inc.
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 …
Spectranetics Corporation
PVP SOLUTION SING STRL, REF DYNDA1858
MEDLINE INDUSTRIES, LP - Northfield
Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b…
SUGARMDS LLC
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, C…
Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Staar Surgical Company
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Integra LifeSciences Corp.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect …
CooperSurgical, Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Staar Surgical Company
Stay Safe Cap
Fresenius Medical Care Holdings, Inc.
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Staar Surgical Company
DRX Revolution Mobile X-Ray System
Carestream Health, 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 2, 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 2, 2026.