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 · 2026-09-02
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 729 of 822
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
CareFusion 303, Inc.
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the p…
GE OEC Medical Systems, Inc
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, …
Philips Medical Systems (Cleveland) Inc
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Pr…
Ortho-Clinical Diagnostics
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Terumo Cardiovascular Systems Corp
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Cathete…
Codman & Shurtleff, Inc.
Summer Infant Expands Recall to Replace Video Monitor Rechargeable Batteries Due to Burn Hazard
Ontel Recalls Isometric Exercise Devices Due to Projectile Hazard
Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
Breg Inc
Cocaine Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
EDDP Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Barbiturate Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Ketamine Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-…
Pega Medical Inc.
Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic…
Smiths Medical ASD, Inc.
10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Tramadol Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Amphetamine Strip; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for clo…
Aspen Surgical Products, Inc.
Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Methadone Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
THC Test Card; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Aspen Surgical Products, Inc.
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of mul…
Clinical Diagnostic Solutions
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrill…
Philips Medical Systems, Inc.
400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient …
ErgoSafe Product LLC dba Prism Medical Services
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 9…
Intuitive Surgical, Inc.
Legionella Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 9…
Intuitive Surgical, Inc.
Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054
LumiQuick Diagnostics Inc.
Morphine Strip (300); LumiQuick, Santa Clara, CA 95054
LumiQuick Diagnostics 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 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.