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 286 of 819

FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460

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

Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.

Hardy Diagnostics
FDA Devices Critical Jun 16, 2021

COVID-19 Self-Test Kit *** INNOVA *** 3T

INNOVA MEDICAL GROUP, INC.
FDA Devices Moderate Jun 16, 2021

RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8…

RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699

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

Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385

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

ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with …

Viewray, Inc.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, Non-Sterile, UDI: (01)00190376268743

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

Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be u…

Medline Industries Inc
FDA Devices Moderate Jun 16, 2021

Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

Normand-Info S.A.S.U.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620

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

CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional…

CooperSurgical, Inc.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446

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

VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the …

MICROVENTION INC.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, Non-Sterile, UDI: (01)00190376268408

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

Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, Non-Sterile, UDI: (01)00190376268637

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

Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569

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

VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the …

MICROVENTION INC.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477

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

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

DeRoyal Industries Inc
FDA Devices Critical Jun 16, 2021

For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

INNOVA MEDICAL GROUP, INC.
FDA Devices Moderate Jun 16, 2021

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque buil…

Sunstar Americas, Inc.
FDA Devices Critical Jun 16, 2021

ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04

Avid Medical, Inc.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, Non-Sterile, UDI: (01)00190376268378

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

Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613

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

Olympus Sterile Optical Laser Fiber, single use and reusable

Quanta System, S.p.A.
FDA Devices Moderate Jun 16, 2021

Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide corre…

Medtronic Sofamor Danek USA, Inc
FDA Devices Moderate Jun 16, 2021

Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X

Philips North America Llc
FDA Devices Moderate Jun 16, 2021

ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accura…

Brainlab AG
FDA Devices Critical Jun 16, 2021

JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF …

Smiths Medical ASD Inc.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538

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

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

DeRoyal Industries Inc
FDA Devices Critical Jun 16, 2021

FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

Avid Medical, Inc.
FDA Devices Moderate Jun 16, 2021

Quanta System Sterile Optical Laser Fiber, single use

Quanta System, S.p.A.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, Non-Sterile, UDI: (01)00190376268361

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

Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, Non-Sterile, UDI: (01)00190376268439

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

Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422

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

Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-Level, 19 mm, Rx Only, Non-Sterile, UDI: (01)00190376268453

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

VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the …

MICROVENTION INC.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507

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

Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

Philips North America Llc
FDA Devices Critical Jun 16, 2021

COVID-19 Self-Test Kit *** INNOVA *** 7T

INNOVA MEDICAL GROUP, INC.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606

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

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: AR…

DePuy Orthopaedics, Inc.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415

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

Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, Non-Sterile, UDI: (01)00190376268712

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

WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835N…

Wishbone Medical, Inc.
FDA Devices Moderate Jun 16, 2021

Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-Level, 56 mm, Rx Only, Non-Sterile, UDI: (01)00190376268590

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

Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-Level, 78 mm, Rx Only, Non-Sterile, UDI: (01)00190376268705

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

Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, Non-Sterile, UDI: (01)00190376268392

Alphatec Spine, 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.

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.