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 publisher.
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 · 2026-08-24

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 500 of 819

FDA Devices Moderate Mar 7, 2018

SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectiona…

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 7, 2018

MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and a…

Medistim Asa
FDA Devices Moderate Mar 7, 2018

Truth Renew

Accord Media, LLC
FDA Devices Moderate Mar 7, 2018

AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…

Steris Corporation
FDA Devices Critical Mar 7, 2018

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

Ventana Medical Systems Inc
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Product Usage: The Vis-U-All High Temperature Steriliza…

Steris Corporation
FDA Devices Moderate Mar 7, 2018

Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.

Zimmer Biomet, Inc.
FDA Devices Moderate Mar 7, 2018

AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 7, 2018

AVID TruCustom SPINE convenience kits, Item Code: LITT016-04

Avid Medical, Inc.
FDA Devices Critical Mar 7, 2018

OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic

Ventana Medical Systems Inc
FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection …

Zevex Incorporated (dba Moog Medical Medical Devices Group)
FDA Devices Moderate Mar 7, 2018

AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4166, Non-DEHP Microbore Tubing with Non-Vented Spike, Anti-Siphon Valve included for Free Flow Prot…

Zevex Incorporated (dba Moog Medical Medical Devices Group)
FDA Devices Moderate Mar 7, 2018

digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGr…

Philips Electronics North America Corporation
FDA Devices Moderate Mar 7, 2018

V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)

Steris Corporation
FDA Devices Moderate Mar 7, 2018

Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 7, 2018

NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK304…

NxStage Medical, Inc.
FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check V…

Zevex Incorporated (dba Moog Medical Medical Devices Group)
FDA Devices Moderate Mar 7, 2018

STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set …

ConMed Corporation
FDA Devices Low Mar 7, 2018

JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate t…

Perkinelmer Life Sciences, Inc.
FDA Devices Moderate Mar 7, 2018

The 2nd Assist Knee Positioner

Zimmer Biomet, Inc.
FDA Devices Moderate Mar 7, 2018

Truth Renew Plus

Accord Media, LLC
FDA Devices Moderate Mar 7, 2018

Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 008943019…

Zimmer Biomet, Inc.
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Sterilizat…

Steris Corporation
FDA Devices Critical Mar 7, 2018

ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

Ventana Medical Systems Inc
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization P…

Steris Corporation
FDA Devices Moderate Mar 7, 2018

Syngo.via systems with SW VB20A

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 7, 2018

ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgic…

Atrium Medical Corporation
FDA Devices Moderate Mar 7, 2018

Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument

Zimmer Biomet, Inc.
FDA Devices Moderate Mar 7, 2018

AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)

Circulatory Technology Inc
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouc…

Steris Corporation
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs Product Usage: The Vis-U-All High Temperature Steriliz…

Steris Corporation
FDA Devices Moderate Mar 7, 2018

MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with the MOOG Cu…

Zevex Incorporated (dba Moog Medical Medical Devices Group)
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Po…

Steris Corporation
FDA Devices Moderate Mar 7, 2018

AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239

Tosoh Bioscience Inc
FDA Devices Moderate Mar 7, 2018

Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights f…

Stryker Communications
FDA Devices Moderate Mar 7, 2018

Ultra Renew

Accord Media, LLC
FDA Devices Moderate Mar 7, 2018

2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

Fresenius Medical Care Renal Therapies Group, LLC
FDA Devices Moderate Mar 7, 2018

Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulou…

Keystone Dental Inc
FDA Devices Moderate Mar 7, 2018

AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03

Avid Medical, Inc.
FDA Devices Moderate Mar 7, 2018

Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848283 & 10848354

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 7, 2018

Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6 rolls/cs Product Usage: The Vis-U-All High Temperature Steriliz…

Steris Corporation
FDA Devices Moderate Feb 28, 2018

Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a si…

Medtronic Perfusion Systems
FDA Devices Moderate Feb 28, 2018

Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-…

Arrow International 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.