Product category · Updated Aug 19, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
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 174 of 822
BLOOD CULTURE KIT, REF DYNDH1647B
MEDLINE INDUSTRIES, LP - Northfield
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
Atrium Medical Corporation
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Philips North America
LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Physio-Control, Inc.
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Physio-Control, Inc.
Mobilett Mira wireless (VA20) mobile x-ray system(s)
Siemens Medical Solutions USA, Inc
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Atrium Medical Corporation
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Ion Beam Applications S.A.
LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
Physio-Control, Inc.
24 BLOOD CULTURE KIT, REF DYNDH1632
MEDLINE INDUSTRIES, LP - Northfield
LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Physio-Control, Inc.
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
Beckman Coulter Biomedical Division
LYFO-DISK, P. venetum, Catalog number 0794L
Microbiologics Inc
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Physio-Control, Inc.
CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
MEDLINE INDUSTRIES, LP - Northfield
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
Philips North America Llc
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Olympus Corporation of the Americas
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Pulmonx, Corp.
MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
Family Dollar Stores, Llc.
EVIS EXERA III Gastrointestinal Videoscope
Olympus Corporation of the Americas
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
Stryker Corporation
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Philips North America Llc
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Edwards Lifesciences, LLC
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Maquet Medical Systems USA
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Stryker Corporation
DENTEMP ONE STEP .077OZ, SKU 902139
Family Dollar Stores, Llc.
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
Ortho-Clinical Diagnostics, INc.
Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
Securitas Healthcare LLC
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Encore Medical, LP
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens
Carestream Health, Inc.
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Olympus Corporation of the Americas
Allura Xper IGTS Fixed Systems
Philips North America
FIRST RESPONSE 2 CT, SKU 902343
Family Dollar Stores, Llc.
Alaris PCA Module 8120
CareFusion 303, Inc.
BD Alaris Syringe Module, REF 8110
CareFusion 303, Inc.
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Philips North America
ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
Family Dollar Stores, Llc.
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
Stryker Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Percussionaire Corporation
TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
B. Braun Medical, Inc.
Veradius Unity Mobile Surgery C-arm
Philips North America
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Stryker Corporation
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
Magellan Diagnostics, Inc.
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Philips North America Llc
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Philips Ultrasound, Inc.
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
Olympus Corporation of the Americas
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
Stryker 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.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
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.