Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 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 176 of 808
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, design…
Davol, Inc.
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to…
Boston Scientific Corporation
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
MEDLINE INDUSTRIES, LP - Northfield
Trexo Device
Trexo Robotics Holdings Inc.
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngea…
Qiagen GmbH
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Amb…
Siemens Medical Solutions USA, Inc
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN:…
Boston Scientific Corporation
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descriptio…
Datascope Corp.
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Datascope Corp.
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Medtronic Neuromodulation
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urologica…
Boston Scientific Corporation
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Argon Medical Devices, Inc
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UP…
Boston Scientific Corporation
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Datascope Corp.
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally…
Hamilton Medical, Inc.
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descripti…
Datascope Corp.
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, desi…
Davol, Inc.
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description …
Datascope Corp.
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Davol, Inc.
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description…
Datascope Corp.
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urologic…
Boston Scientific Corporation
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urolo…
Boston Scientific Corporation
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC:…
New England Life Care, Inc. dba Advanced Compounding Solutions
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801…
New England Life Care, Inc. dba Advanced Compounding Solutions
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE…
MEDLINE INDUSTRIES, LP - Northfield
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Olympus Corporation of the Americas
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR P…
MEDLINE INDUSTRIES, LP - Northfield
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Olympus Corporation of the Americas
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b.…
MEDLINE INDUSTRIES, LP - Northfield
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Digisonics, Inc
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VA…
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Mode…
MEDLINE INDUSTRIES, LP - Northfield
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a c…
Cytocell Ltd.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PAC…
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
MEDLINE INDUSTRIES, LP - Northfield
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-…
Datascope Corp.
Impella LD intravascular micro axial blood pump, Product Number 005082
Abiomed, Inc.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b)…
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSE…
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1…
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND…
MEDLINE INDUSTRIES, LP - Northfield
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Abiomed, Inc.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PA…
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTER…
MEDLINE INDUSTRIES, LP - Northfield
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Datascope Corp.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND …
MEDLINE INDUSTRIES, LP - Northfield
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Olympus Corporation of the Americas
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 2, 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 2, 2026.