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 253 of 819

FDA Devices Moderate Apr 6, 2022

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Edwards Lifesciences, LLC
FDA Devices Moderate Apr 6, 2022

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-…

InfuTronix LLC
FDA Devices Moderate Apr 6, 2022

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Roche Molecular Systems, Inc.
FDA Devices Low Apr 6, 2022

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

ROi CPS LLC
FDA Devices Moderate Apr 6, 2022

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Ansell Healthcare Products LLC
FDA Devices Moderate Apr 6, 2022

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive C…

Microbiologics Inc
FDA Devices Moderate Apr 6, 2022

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Baxter Healthcare Corporation
FDA Devices Moderate Apr 6, 2022

BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

Avanos Medical, Inc.
FDA Devices Moderate Apr 6, 2022

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Mevion Medical Systems, Inc.
FDA Devices Moderate Apr 6, 2022

Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimen…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 6, 2022

Hanger-Bar 2P 45cm

Human Care USA, Inc.
FDA Devices Moderate Apr 6, 2022

RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7…

RAYSEARCH LABORATORIES AB
FDA Devices Moderate Apr 6, 2022

TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61…

RAYSEARCH LABORATORIES AB
FDA Devices Moderate Apr 6, 2022

Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

Baxter Healthcare Corporation
FDA Devices Moderate Apr 6, 2022

EasyFuse Dynamic Compression System Instrument Pack

Wright Medical Technology, Inc.
FDA Devices Moderate Apr 6, 2022

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastic…

Carefusion 2200 Inc
FDA Devices Moderate Apr 6, 2022

Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032

Howmedica Osteonics Corp.
FDA Devices Moderate Apr 6, 2022

Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Apr 6, 2022

RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), Ray…

RaySearch America Inc
FDA Devices Moderate Apr 6, 2022

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

Illumina, Inc.
FDA Devices Moderate Apr 6, 2022

MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; …

Medtronic MiniMed
FDA Devices Low Mar 30, 2022

Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

Cytocell Ltd.
FDA Devices Moderate Mar 30, 2022

Compella Therapy Air Supply Unit

Baxter Healthcare Corporation
FDA Devices Moderate Mar 30, 2022

Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. The…

Dollar Tree Distribution, Inc.
FDA Devices Low Mar 30, 2022

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog N…

Cytocell Ltd.
FDA Devices Moderate Mar 30, 2022

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebros…

Integra LifeSciences Corp.
FDA Devices Moderate Mar 30, 2022

BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed …

Biomet, Inc.
FDA Devices Moderate Mar 30, 2022

NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

Ace Surgical Supply Co., Inc.
FDA Devices Moderate Mar 30, 2022

BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. De…

Biomet, Inc.
FDA Devices Moderate Mar 30, 2022

BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRA…

Biomet, Inc.
FDA Devices Moderate Mar 30, 2022

BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12…

Biomet, Inc.
FDA Devices Moderate Mar 30, 2022

Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

Outset Medical, Inc.
FDA Devices Moderate Mar 30, 2022

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebros…

Integra LifeSciences Corp.
FDA Devices Moderate Mar 30, 2022

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 871…

B Braun Medical Inc
FDA Devices Moderate Mar 30, 2022

Compella Bariatric Bed System

Baxter Healthcare Corporation
FDA Devices Moderate Mar 30, 2022

Azurion systems with software release R2.0.x

Philips Healthcare
FDA Devices Critical Mar 30, 2022

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and…

Philips Respironics, Inc.
FDA Devices Moderate Mar 30, 2022

DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20…

Dignitana, Inc.
FDA Drug Moderate Mar 23, 2022

Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville
FDA Drug Moderate Mar 23, 2022

Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville
FDA Drug Moderate Mar 23, 2022

Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville
FDA Drug Moderate Mar 23, 2022

Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville
FDA Drug Moderate Mar 23, 2022

Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville
FDA Drug Moderate Mar 23, 2022

Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville
FDA Drug Moderate Mar 23, 2022

Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 44-20MM/450CM Material Number: M00583060

Boston Scientific Corporation
FDA Devices Low Mar 23, 2022

LYFO Disk

Microbiologics Inc
FDA Devices Moderate Mar 23, 2022

JAGTOME RX 44-20-260-035 Material Number: M00573040

Boston Scientific Corporation
FDA Devices Moderate Mar 23, 2022

SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

Sam Medical Products
FDA Devices Moderate Mar 23, 2022

HYDRATOME RX 49-20MM/260CM Material Number: M00583000

Boston Scientific Corporation

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.