PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-28

Do more recalls mean more Class I danger?

Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-28. 2×2 strategic matrix plotting 7 entities by Total recalls (count) (X) and Class I share of classified (%) (Y), with a crosshair dividing the plot into four quadrants. Large · Class I–heavySmaller · Class I–heavyLarge · fewer Class ISmaller · fewer Class I 010,00020,00030,00040,00050,000 0%20%40%60%80% Total recalls (count) Class I share of classified (%) Category volume vs Class I rate Signature insight Medical DevicesFoodDrugs & MedicationsChildren & Baby ProductsDietary SupplementsMeat & PoultryCosmetics & Personal Care
Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-28.
Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

CategoryRecallsVol %ileClassifiedClass IClass I %Rate %ile
Medical Devices41,07010040,7633,6539%14
Food25,5138625,22211,67646.3%86
Drugs & Medications14,4737114,4171,50810.5%29
Children & Baby Products4,017572,48335214.2%43
Dietary Supplements2,018431,99346623.4%71
Meat & Poultry1,672291,6721,14568.5%100
Cosmetics & Personal Care1,388141,28920315.7%57

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 169 of 822

FDA Devices Moderate Dec 20, 2023

RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

Encore Medical, LP
FDA Devices Moderate Dec 20, 2023

STERILE PVP SOLUTION, REF DYNDA1907

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

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 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

Riverpoint Medical, LLC
FDA Devices Moderate Dec 20, 2023

Medline Leg bag, REF URO12573

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

STERILE POVIDONE, REF DYNDA2061

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

Medline Leg bag, REF DYND12574

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgr

GE Hangwei Medical Systems, Co. LTD
FDA Devices Critical Dec 20, 2023

Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.

Philips North America Llc
FDA Devices Moderate Dec 20, 2023

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

CHANGE HEALTHCARE CANADA COMPANY
FDA Devices Moderate Dec 20, 2023

VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Dec 20, 2023

STERILE BETADINE, REF DYNDA1998

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312

Meridian Bioscience Inc
FDA Devices Moderate Dec 20, 2023

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

Olympus Corporation of the Americas
FDA Devices Low Dec 20, 2023

Navik 3D v2, REF NAVIK3D, 3D Mapping System

APN Health LLC
FDA Devices Moderate Dec 20, 2023

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Meridian Bioscience Inc
FDA Devices Moderate Dec 20, 2023

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Baxter Healthcare Corporation
FDA Devices Moderate Dec 20, 2023

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

Limacorporate S.p.A
FDA Devices Moderate Dec 20, 2023

Medline Leg bag, REF DYND12578

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Dec 20, 2023

CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)

Maquet Medical Systems USA
FDA Devices Moderate Dec 20, 2023

STERILE PVP, REF DYNDA1649

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient s age, previous biopsy, and digital rectal exam (DRE).

BioReference Health, LLC
FDA Devices Moderate Dec 20, 2023

STERILE STERILE PREP STICK, REF DYNDA1134

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Dec 20, 2023

The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgr

GE Hangwei Medical Systems, Co. LTD
FDA Devices Moderate Dec 20, 2023

Medtronic SynchroMed, Model A10

Medtronic Inc.
FDA Devices Moderate Dec 20, 2023

SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System

Bebig Isotopentechnik Gmbh
FDA Devices Moderate Dec 20, 2023

STERILE PVP SLN KIT, REF DYNDM1097

MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Critical Dec 20, 2023

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

Integra LifeSciences Corp.
FDA Devices Moderate Dec 20, 2023

Sensica Urine Output System, Catalog Number SCCS1002

C.R. Bard Inc
FDA Devices Moderate Dec 20, 2023

VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Dec 20, 2023

Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312

Meridian Bioscience Inc
FDA Devices Moderate Dec 20, 2023

ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Dec 20, 2023

VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Dec 20, 2023

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 Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

Spectranetics Corporation
FDA Devices Moderate Dec 20, 2023

PVP SOLUTION SING STRL, REF DYNDA1858

MEDLINE INDUSTRIES, LP - Northfield
FDA Drug Critical Dec 13, 2023

Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.

SUGARMDS LLC
FDA Drug Low Dec 13, 2023

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, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1

Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
FDA Devices Moderate Dec 13, 2023

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Staar Surgical Company
FDA Devices Moderate Dec 13, 2023

Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040

Integra LifeSciences Corp.
FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.
FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.
FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005

CooperSurgical, Inc.
FDA Devices Moderate Dec 13, 2023

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.
FDA Devices Moderate Dec 13, 2023

EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

Staar Surgical Company
FDA Devices Moderate Dec 13, 2023

Stay Safe Cap

Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Dec 13, 2023

EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Staar Surgical Company
FDA Devices Moderate Dec 13, 2023

DRX Revolution Mobile X-Ray System

Carestream Health, Inc.
FDA Devices Moderate Dec 13, 2023

Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

Integra LifeSciences Corp.

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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.