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
Compiled from official public sources by the editorial process.
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

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 287 of 819

FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675

Alphatec Spine, Inc.
FDA Devices Critical Jun 16, 2021

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06

DeRoyal Industries Inc
FDA Devices Moderate Jun 16, 2021

NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perf…

Nico Corp.
FDA Devices Moderate Jun 9, 2021

Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

Vygon U.S.A.
FDA Devices Moderate Jun 9, 2021

Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and sta…

Zimmer GmbH
FDA Devices Moderate Jun 9, 2021

Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid …

CLINICAL LASERTHERMIA SYSTEMS AB
FDA Devices Moderate Jun 9, 2021

Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM…

CHANGE HEALTHCARE CANADA COMPANY
FDA Devices Moderate Jun 9, 2021

10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving fe…

Flower Orthopedics Corporation
FDA Devices Moderate Jun 9, 2021

ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term …

Draeger Medical, Inc.
FDA Devices Moderate Jun 9, 2021

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of …

CLINICAL LASERTHERMIA SYSTEMS AB
FDA Devices Moderate Jun 9, 2021

10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ M…

CLINICAL LASERTHERMIA SYSTEMS AB
FDA Devices Moderate Jun 9, 2021

REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

Meta C.G.M. Spa
FDA Devices Moderate Jun 9, 2021

ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and s…

Zimmer GmbH
FDA Devices Moderate Jun 9, 2021

Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term res…

Draeger Medical, Inc.
FDA Devices Moderate Jun 9, 2021

InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Critical Jun 9, 2021

Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antib…

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
FDA Devices Moderate Jun 9, 2021

The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to…

Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Jun 9, 2021

ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud

Elekta, Inc.
FDA Devices Moderate Jun 9, 2021

ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for …

K2M, Inc
FDA Devices Moderate Jun 9, 2021

VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term res…

Draeger Medical, Inc.
FDA Devices Moderate Jun 9, 2021

The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal …

Terumo Cardiovascular Systems Corporation
FDA Devices Moderate Jun 9, 2021

10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.

Zavation
FDA Devices Moderate Jun 9, 2021

MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF M…

Medtronic Minimed
FDA Devices Moderate Jun 9, 2021

Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for …

K2M, Inc
FDA Devices Moderate Jun 9, 2021

Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term …

Draeger Medical, Inc.
FDA Devices Moderate Jun 9, 2021

10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.

Zavation

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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

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.