Product category · Updated Jul 29, 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 (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
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
40,910 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 · NHTSA federal recall filings · 2026-08-24
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 492 of 819
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician…
Vascular Insights, LLC
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfat…
Epigenomics Ag
REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, c…
Medical Components, Inc dba MedComp
CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her co…
Medical Components, Inc dba MedComp
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional pro…
Siemens Medical Solutions USA, Inc
J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
Bovie Medical Corporation
DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily ap…
Ethicon, Inc.
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee…
OMNIlife science Inc.
MINI PLASTICS SET
Centurion Medical Products Corporation
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Bovie Medical Corporation
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and so…
Beckman Coulter Inc.
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee…
United Orthopedic Corporation
TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her conn…
Medical Components, Inc dba MedComp
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to…
Boston Scientific Corporation
Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used…
Covidien LLC
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems develope…
Siemens Medical Solutions USA, Inc
SorbaView Shield Dressing Change Tray
Centurion Medical Products Corporation
SwishTapered Implant Intended for use in support for fixed bridgework.
Implant Direct Sybron Manufacturing, LLC
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Bovie Medical Corporation
Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish…
Boston Scientific Corporation
BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
Becton Dickinson & Company
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Boston Scientific Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for …
United Orthopedic Corporation
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA52…
ESAOTE S.P.A.
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiri…
Smiths Medical ASD Inc.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
NxStage Medical, Inc.
BLOOD DRAW KIT
Centurion Medical Products Corporation
CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her …
Medical Components, Inc dba MedComp
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed…
Boston Scientific Corporation
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
ESAOTE S.P.A.
MINOR DRESSING CHANGE TRAY
Centurion Medical Products Corporation
REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, cla…
Medical Components, Inc dba MedComp
EXCISION TRAY
Centurion Medical Products Corporation
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Prec…
Arrow International Inc
WOUND CARE KIT
Centurion Medical Products Corporation
GENICON EZEE Retrieval, sterile, Rx only.
Genicon, Inc.
INCISION & DRAINAGE TRAY or KIT
Centurion Medical Products Corporation
AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number …
Beckman Coulter Inc.
TUBING CHANGE KIT
Centurion Medical Products Corporation
J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
Bovie Medical Corporation
WOUND CLOSURE TRAY - FACIAL
Centurion Medical Products Corporation
12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged…
Medical Components, Inc dba MedComp
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Merit Medical Systems, Inc.
BD Vacutainer¿ EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 5038290366…
Becton Dickinson & Company
SKIN STAPLE REMOVER
Centurion Medical Products Corporation
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
Merit Medical Systems, Inc.
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to…
Boston Scientific Corporation
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central ci…
Arrow International Inc
Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The Malecot Nephrostomy Catheter Set is intended to establish…
Boston Scientific Corporation
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Merit Medical Systems, 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 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.