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 · 2026-09-04
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 819 of 822
SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary b…
Terumo Cardiovascular Systems Corporation
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic an…
Covidien LP
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use …
Natus Medical Incorporated
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30)…
Hospira, Inc.
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical tea…
Stryker Instruments Div. of Stryker Corporation
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling cathete…
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are…
Vygon Corporation
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter…
Vygon Corporation
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phos…
Integra LifeSciences Corp.
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of…
Vygon Corporation
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d …
General Electric Med Systems LLC
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are …
Vygon Corporation
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of…
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are…
Vygon Corporation
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction…
Philips Medical Systems (Cleveland) Inc
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of ind…
Vygon Corporation
Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat colle…
MicroAire Surgical Instruments, LLC
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The…
General Electric Med Systems LLC
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter…
Vygon Corporation
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in …
Aesculap Implant Systems
Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-…
Integra LifeSciences Corp.
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generatin…
General Electric Med Systems LLC
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to mai…
Vygon Corporation
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Philips Healthcare Inc.
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class…
Baxter Healthcare Corporation
PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system tha…
Plasma Surgical Inc.
T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team…
Stryker Instruments Div. of Stryker Corporation
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter…
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are …
Vygon Corporation
Gems Sensors Recalls Pressure Transducers Used in Fire Pump Controllers Due to Risk of Failure in a Fire
Lenovo Expands Recall of ThinkCentre Desktop Computers Due to Fire Hazard
Lenovo, of Morrisville, N.C.
XS Scuba Recalls Miflex High Pressure Diving Hoses Due to Drowning Hazard
Miflex 2, Villasanta, Italy
Safety 1st Cabinet Locks Recalled Due to Lock Failure; Children Can Gain Unintended Access to Dangerous Items
Lenovo Recalls ThinkCentre Desktop Computers Due to Fire Hazard
Lenovo, of Morrisville, N.C.
Nidec Motor Corporation Recalls Pool Pump Motors Due to Electrical Shock Hazard
Nidec Motor Corporation, of St. Louis, Mo.
Petzl America Recalls Belay Devices Due to Fall Hazard
Petzl SAS, of Crolles, France
Cloud Engines Recalls Pogoplug Video File Sharing Device Due to Fire Hazard
Sea Elite Systems Recalls Buoyancy Control Devices Due to Drowning Hazard
WRK Enterprises Recalls Edge and HOG Buoyancy Control Devices Due to Drowning Hazard
Spot Recalls Satellite Communicator Due To Loss of Emergency Communications Capability
Spot LLC, of Covington, La.
ADP Recalls to Repair Unit Heaters Due to Fire Hazard1
Lennox Industries Inc., of Richardson, Texas
Lennox Industries Recalls to Repair Garage Heaters Due to Fire Hazard
Lennox Industries Inc., of Richardson, Texas
Sunbeam Products Recalls Wine Openers Due to Laceration Hazard; Sold by QVC
Sunbeam Products Inc., of Boca Raton, Fla.
Rechargeable Batteries in Video Baby Monitors Recalled to Replace by Summer Infant Due to Burn Hazard; Sold Exclusively at Babies R Us
MP and BK, of China
Two Strangulation Deaths Prompt Summer Infant to Recall Video Baby Monitors with Cords; Firm to Provide New On-Product Label & Instructions
Briggs & Stratton Recalls Model 40 V-Twin Engine Due to Injury Hazard; Used on Sears, Husqvarna, Bad Boy Riding Mowers
Briggs & Stratton Corporation, Milwaukee, Wis.
Safety Vacuum Release System Recalled by Vacless Systems Inc. for a Repair/Replace Program to Prevent Entrapment
Vacless Systems Inc., of Sylmar, Calif.
ITT Water Technology Recalls Pumps Due to Electric Shock/Electrocution Hazard
Camping Stoves and Equipment Recalled by Katadyn North America Due to Fire Hazard
Strangulation Death of a Child Prompts Recall of Roman Shades, Roll-Up Blinds, and Roller Blinds by Hanover Direct/Domestications
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.