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 30 of 810
Organic acids Test
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IntelliVue MP20. Product Number: M8001A.
Philips North America Llc
Hair Mineral Analysis
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IntelliVue Patient Monitor MX600. Product Number: 865242.
Philips North America Llc
Gut Microbiome Test Large
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Chlamydia Test
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Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 200288…
Illumina, Inc.
Gonorrhea test
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Cholesterol Test
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Iron Deficiency Test (ferritin)
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Thyroid TSH Test
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Herpes (HSV-1 & HSV-2) Test
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Iron Deficiency Test
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Diabetes Test (ketones & glucose)
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Liver Test
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IntelliVue Patient Monitor MX400. Product Number: 866060.
Philips North America Llc
Pregnancy Test
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Allergy & Food Intolerance Test
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Ovulation Test (5 tests)
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IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Philips North America Llc
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation Sys…
Accriva Diagnostics, Inc.
Food Sensitivity Test Medium
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Olympus OER-Pro
Aizu Olympus Co., Ltd.
Men s Hormone Test
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H pylori (Peptic ulcer) Test
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MAMMOMAT Revelation;
Siemens Medical Solutions USA, Inc
IntelliVue Patient Monitor MX550. Product Number: 866066.
Philips North America Llc
Neurotransmitters Basic
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Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
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Fecal Occult Blood Test
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IntelliVue Patient Monitor MX750. Product Number: 866471.
Philips North America Llc
Women s Hormone Test
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Melatonin Test
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Olympus OER-Mini
Aizu Olympus Co., Ltd.
IntelliVue Patient Monitor MX450. Product Number: 866062.
Philips North America Llc
Neurotransmitters XL
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IBS Test
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Sorbitol Intolerance Test
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Environmental Pollutants Profile Test
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Vaginal PH Test
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Gut Microbiome Test Medium
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Estrogen & Progesterone Test
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IntelliVue MP70. Product Number: M8007A.
Philips North America Llc
Continuous Glucose Monitor (CGM)
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INIU Recalls Power Banks Due to Fire and Burn Hazards; Sold on Amazon
Shenzhen Topstar Industry Co., Ltd., of China
Grizzly Industrial Recalls Heavy-Duty Planers Due to Impact and Laceration Hazards
Primark US Recalls Primark Water Balloon Pumps Due to Injury Hazard
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pu…
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump,…
B Braun Medical Inc
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pu…
B Braun Medical 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.
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.