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 510 of 819
BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from …
Dukal Corp.
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
Terumo Medical Corp
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and Bi…
Angiodynamics Inc. (Navilyst Medical Inc.)
XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and …
Angiodynamics Inc. (Navilyst Medical Inc.)
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
Terumo Medical Corp
enGen Track System with TCAutomation Software Version 4.2
Ortho-Clinical Diagnostics
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to ge…
Fujifilm Medical Systems U.S.A., Inc.
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects …
Normand Informatique
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
Angiodynamics Inc. (Navilyst Medical Inc.)
United Nuclear Scientific High Power Handheld Lasers. Laser products
United Nuclear Scientific Supplies, LLC
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cerv…
Amendia, Inc dba Spinal Elements
Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFl…
Angiodynamics Inc. (Navilyst Medical Inc.)
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela wi…
Angiodynamics Inc. (Navilyst Medical Inc.)
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
Terumo Medical Corp
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
Terumo Medical Corp
Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFl…
Angiodynamics Inc. (Navilyst Medical Inc.)
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Elekta Inc
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY
Terumo Medical Corp
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458830, Catalog No. 45-883 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and Bi…
Angiodynamics Inc. (Navilyst Medical Inc.)
ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl ,…
Radiometer America Inc
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
Terumo Medical Corp
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
Angiodynamics Inc. (Navilyst Medical Inc.)
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
Terumo Medical Corp
LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R…
Physio-Control, Inc.
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
Terumo Medical Corp
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology,…
Angiodynamics Inc. (Navilyst Medical Inc.)
UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
Beckman Coulter Inc.
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and Bi…
Angiodynamics Inc. (Navilyst Medical Inc.)
Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single pati…
Novo Nordisk Inc
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Dra…
DeRoyal Industries Inc
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size…
Intersurgical Inc
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating f…
Becton Dickinson & Co.
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number…
Roche Diabetes Care, Inc.
SMARTABLATE RF System Generator
Biosense Webster, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheu…
Exactech, Inc.
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, i…
Becton Dickinson & Company
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R…
Pro-Med Instruments Gmbh
BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID b…
Becton Dickinson & Co.
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing …
Won Industry Co.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended t…
GE Medical Systems Information Technologies, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Biosense Webster, Inc.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor …
Fukuda Denshi Co., Ltd.
ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 1603…
ICU Medical Inc
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe r…
Exactech, Inc.
CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Remel 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.