Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 29 of 810
MAMMOMAT Fusion;
Siemens Medical Solutions USA, Inc
IntelliVue MP2. Product Number: M8102A.
Philips North America Llc
Food Sensitivity Test Large
GET TESTED INTERNATIONAL AB
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump A…
Fresenius Kabi USA, LLC
Mycotoxin Panel Test
GET TESTED INTERNATIONAL AB
Food Sensitivity Test Small
GET TESTED INTERNATIONAL AB
Allergy test Small
GET TESTED INTERNATIONAL AB
Peptic Ulcer Test (H, pylori)
GET TESTED INTERNATIONAL AB
Heavy Metals Test
GET TESTED INTERNATIONAL AB
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Philips North America Llc
Fructose Intolerance Test
GET TESTED INTERNATIONAL AB
Trichomonas Vaginalis test
GET TESTED INTERNATIONAL AB
IntelliVue MP50. Product Number: M8004A.
Philips North America Llc
SIBO Test
GET TESTED INTERNATIONAL AB
IntelliVue MP80. Product Number: M8008A.
Philips North America Llc
IntelliVue Patient Monitor MX100. Product Number: 867033.
Philips North America Llc
Intestinal Worms Test
GET TESTED INTERNATIONAL AB
D-Dimer Test
GET TESTED INTERNATIONAL AB
IntelliVue MP40. Product Number: M8003A.
Philips North America Llc
Diabetes HbA1c Test
GET TESTED INTERNATIONAL AB
Olympus OER-Elite
Aizu Olympus Co., Ltd.
Candida Test
GET TESTED INTERNATIONAL AB
Syphilis Test
GET TESTED INTERNATIONAL AB
Iodine Test
GET TESTED INTERNATIONAL AB
MPOX Test
GET TESTED INTERNATIONAL AB
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Medtronic, Inc.
GI Microbiome Profile Small
GET TESTED INTERNATIONAL AB
Parasite Test
GET TESTED INTERNATIONAL AB
Sperm Test
GET TESTED INTERNATIONAL AB
DHEA Test
GET TESTED INTERNATIONAL AB
Serotonin Test
GET TESTED INTERNATIONAL AB
Female Fertility Test
GET TESTED INTERNATIONAL AB
Gut Microbiome Test Mega
GET TESTED INTERNATIONAL AB
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Philips North America Llc
Food Allergy Panel Test (IgE)
GET TESTED INTERNATIONAL AB
Food Intolerance Test Large
GET TESTED INTERNATIONAL AB
NAD Profile Test
GET TESTED INTERNATIONAL AB
Vitamin D2 and D3 Test
GET TESTED INTERNATIONAL AB
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patie…
Enterix, Inc.
Leaky Gut Test
GET TESTED INTERNATIONAL AB
Kidney Test
GET TESTED INTERNATIONAL AB
2 in 1 Trichomonas / Gardnerella Test
GET TESTED INTERNATIONAL AB
Menopause (FSH) 2 Tests
GET TESTED INTERNATIONAL AB
Blood Type Test
GET TESTED INTERNATIONAL AB
3 in 1 STI Test
GET TESTED INTERNATIONAL AB
IntelliVue MP60. Product Number: M8005A.
Philips North America Llc
Biological Age & Longevity Test
GET TESTED INTERNATIONAL AB
Lyme Test
GET TESTED INTERNATIONAL AB
Drug Test Small (4 substances)
GET TESTED INTERNATIONAL AB
IntelliVue MP5. Product Number: M8105A.
Philips North America Llc
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 Jun 3, 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 Jun 3, 2026.