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 · 2026-08-25

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 524 of 819

FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum…

Sentinel CH SPA
FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels

Myelotec, Inc.
FDA Devices Moderate Aug 9, 2017

GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

GE Inspection Technologies, LP
FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guidin…

Greatbatch Medical
FDA Devices Moderate Aug 9, 2017

NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

Soft Computer Consultants, Inc.
FDA Devices Moderate Aug 9, 2017

STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Devices Moderate Aug 9, 2017

Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence

Olympus Scientific Solutions Americas
FDA Devices Moderate Aug 9, 2017

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150

Stryker Neurovascular
FDA Devices Moderate Aug 9, 2017

OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES …

Xintec Corp
FDA Devices Moderate Aug 9, 2017

Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including at…

Spectranetics Corporation
FDA Devices Moderate Aug 9, 2017

SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA

Sorin Group USA, Inc.
FDA Drug Moderate Aug 2, 2017

fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05

SCA Pharmaceuticals
FDA Drug Moderate Aug 2, 2017

Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- N…

SCA Pharmaceuticals
FDA Drug Moderate Aug 2, 2017

ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004…

SCA Pharmaceuticals
FDA Drug Moderate Aug 2, 2017

fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 -…

SCA Pharmaceuticals
FDA Devices Moderate Aug 2, 2017

DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass…

Medtronic Perfusion Systems
FDA Devices Moderate Aug 2, 2017

STOCKERT Heater-Cooler System 3T, 120V/60 Hz

Sorin Group USA, Inc.
FDA Devices Moderate Aug 2, 2017

Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.

Smiths Medical ASD Inc.
FDA Devices Critical Aug 2, 2017

CS 300 Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division
FDA Devices Moderate Aug 2, 2017

STOCKERT Heater-Cooler System 3T, 230 V

Sorin Group USA, Inc.
FDA Devices Moderate Aug 2, 2017

VITEK 2 Gram Negative test kits containing colistin (cs01n)

Biomerieux Inc
FDA Devices Moderate Aug 2, 2017

Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Ca…

Medtronic Navigation, Inc.
FDA Devices Moderate Aug 2, 2017

Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is …

Cardinal Health 200, LLC
FDA Devices Moderate Aug 2, 2017

Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagno…

Fisher Diagnostics
FDA Devices Moderate Aug 2, 2017

DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with fl…

Medtronic Perfusion Systems
FDA Devices Moderate Aug 2, 2017

STOCKERT Heater-Cooler System 3T, 208V/60 Hz

Sorin Group USA, Inc.
FDA Devices Moderate Aug 2, 2017

STOCKERT Heater-Cooler System 3T, 240V/60 Hz

Sorin Group USA, Inc.
FDA Devices Moderate Aug 2, 2017

DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These …

Medtronic Perfusion Systems
FDA Devices Moderate Aug 2, 2017

Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and dr…

Cardinal Health 200, LLC
FDA Devices Critical Aug 2, 2017

CS 100i Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division
FDA Devices Moderate Aug 2, 2017

Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Exp…

Atrium Medical Corporation
FDA Devices Moderate Aug 2, 2017

INVUITY(R) PhotonBlade(TM), REF PB1

Invuity, Inc.
FDA Devices Critical Aug 2, 2017

CS 100 Intra-Aortic Balloon Pump

Maquet Datascope Corp - Cardiac Assist Division
FDA Devices Moderate Aug 2, 2017

Diagnostics Ultrasound System Ultrasounds System Sonimage HS1

Konica Minolta, Inc.
FDA Devices Moderate Aug 2, 2017

Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scient…

Fisher Diagnostics
FDA Devices Moderate Aug 2, 2017

STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz

Sorin Group USA, Inc.
FDA Devices Moderate Aug 2, 2017

DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypa…

Medtronic Perfusion Systems
FDA Devices Moderate Aug 2, 2017

DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

Medtronic Perfusion Systems
FDA Devices Moderate Aug 2, 2017

STOCKERT Heater-Cooler System 3T, 127V/60 Hz

Sorin Group USA, Inc.
FDA Devices Low Aug 2, 2017

PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport …

PerkinElmer Health Sciences, Inc.
FDA Devices Moderate Jul 26, 2017

9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal o…

Pentax of America 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.