PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

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

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

40,910 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · NHTSA federal recall filings · 2026-08-22

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 458 of 819

FDA Devices Moderate Aug 29, 2018

BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better …

Becton Dickinson & Co.

FDA Devices Moderate Aug 29, 2018

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Ortho Kinematics, Inc

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the d…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 29, 2018

GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING O…

GE Healthcare Japan Corporation

FDA Devices Moderate Aug 29, 2018

Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

Handicare Usa Inc

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

O-Two Medical Technologies, Inc.

FDA Devices Moderate Aug 29, 2018

Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare pro…

Philips Electronics North America Corporation

FDA Devices Moderate Aug 29, 2018

EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software applicat…

Ortho Kinematics, Inc

FDA Devices Moderate Aug 29, 2018

Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requi…

LIEBEL-FLARSHEIM COMPANY LLC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4.1 (Stitching Patient Support) 712225

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

MOSAIQ Oncology Information System

Elekta, Inc.

FDA Devices Moderate Aug 29, 2018

CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicat…

In2bones USA, LLC

FDA Devices Moderate Aug 29, 2018

CombiDiagnost R90 (Stitching Patient Support) 709030

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.

Handicare Usa Inc

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording a…

Philips Electronics North America Corporation

FDA Devices Moderate Aug 29, 2018

Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL H…

Stryker GmbH

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicate…

In2bones USA, LLC

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically creat…

Richard Wolf GmbH

FDA Devices Moderate Aug 29, 2018

GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Co…

GE Healthcare Japan Corporation

FDA Devices Moderate Aug 29, 2018

Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digit…

Ortho Kinematics, Inc

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052

Philips Medical Systems Gmbh, DMC

FDA Devices Low Aug 29, 2018

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid…

Euro Diagnostica AB

FDA Devices Moderate Aug 29, 2018

Connecting Bolt, Model 14-442093

Zimmer Biomet, Inc.

FDA Devices Moderate Aug 29, 2018

bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID…

Biomerieux Inc

FDA Devices Moderate Aug 29, 2018

Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures re…

LIEBEL-FLARSHEIM COMPANY LLC

FDA Devices Critical Aug 29, 2018

The Tri-Flo Subglottic Suction System

Vyaire Medical

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under th…

GE Healthcare Japan Corporation

FDA Devices Moderate Aug 29, 2018

DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084

Philips Medical Systems Gmbh, DMC

FDA Devices Moderate Aug 29, 2018

CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro…

CAREstream Medical LLC

FDA Drug Moderate Aug 22, 2018

Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

Ranier's Compounding Laboratory

FDA Devices Moderate Aug 22, 2018

NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024

Nico Corp.

FDA Devices Moderate Aug 22, 2018

S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.

Beekley Corporation

FDA Devices Moderate Aug 22, 2018

38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Ro…

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.

Beekley Corporation

FDA Devices Moderate Aug 22, 2018

PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Moderate Aug 22, 2018

1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 22, 2018

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-…

Arrow International Inc

FDA Devices Moderate Aug 22, 2018

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

Zimmer Biomet, Inc.

FDA Devices Moderate Aug 22, 2018

MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patie…

Mevion Medical Systems, Inc.

FDA Devices Moderate Aug 22, 2018

40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.

ICU Medical de Mexico, S.A. de C.V.

FDA Devices Critical Aug 22, 2018

Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system incl…

Spacelabs Healthcare, Ltd.

FDA Devices Low Aug 22, 2018

Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative a…

Clarity Diagnostics 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

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.