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
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 350 of 819
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Olympus Pleuravideoscope, Model LTF-240
Olympus Corporation of the Americas
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
Boston Scientific
Synaptive ImageDrive Clinical
Synaptive Medical Inc
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
KT Health, LLC
Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue …
Beckman Coulter Inc.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
HEMO-7 Hemospray Endoscopic Hemostat
Wilson-Cook Medical Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, …
Medivators, Inc.
HEMO-10 Hemospray Endoscopic Hemostat
Wilson-Cook Medical Inc.
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with …
bioMerieux, Inc.
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
Smith & Nephew, Inc.
Leviton Manufacturing Recalls Electrical Connection Devices Due to Shock Hazard
Leviton Manufacturing Co. Inc., of Melville, N.Y.
LUS Recalls Hair Dryers Due to Electrocution or Shock Hazard (Recall Alert)
Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Sysmex America, Inc.
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
Canon Medical System, USA, INC.
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only sme…
Sysmex America, Inc.
SPICE (JWH-018) CC443
Carolina Liquid Chemistries Corp
Canon Aquilion Prime SP, Model TSX-303B
Canon Medical System, USA, INC.
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to …
Boddingtons Plastics Ltd
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Greiner Bio-One North America, Inc.
Canon Aquilion Prime, Model TSX-303A
Canon Medical System, USA, INC.
Canon Aquilion Lightning, Model TSX-036A
Canon Medical System, USA, INC.
Canon Aquilion Precision, Model TSX-304A
Canon Medical System, USA, INC.
Canon Aquilion One Vision, Model TSX-301C
Canon Medical System, USA, INC.
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Smiths Medical ASD, Inc.
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Sol…
Merit Medical Systems, Inc.
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The …
Boston Scientific Neuromodulation Corporation
Canon Aquilion Premium, Model TSX-301B
Canon Medical System, USA, INC.
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Smiths Medical ASD, Inc.
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number…
Life Technologies Corporation
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Num…
Life Technologies Corporation
djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, …
Encore Medical, LP
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog …
Life Technologies Corporation
Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Numbe…
Life Technologies Corporation
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicate…
Abbott
Canon Aquilion One, Model TSX-301A
Canon Medical System, USA, INC.
Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.Th…
Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss…
Boston Scientific Neuromodulation Corporation
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)0697…
Shanghai United Imaging Healthcare Co., Ltd.
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - …
CooperSurgical, Inc.
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss…
Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.Th…
Boston Scientific Neuromodulation Corporation
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination o…
Diagnostica Stago, Inc.
NavLock Tracker *** Rx Only
Medtronic Navigation, Inc.
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
PharMEDium Services, LLC
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, …
PharMEDium Services, LLC
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleve…
PharMEDium Services, 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 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.