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 430 of 819
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
Angiotech (Manan Medical Products, Inc.)
Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Ascension Orthopedics, Inc
ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoas…
Abbott Ireland Diagnostics Division
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intend…
Richard Wolf GmbH
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a who…
NEUSOFT MEDICAL SYSTEMS IMP & EX
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The Coag…
TERRIFIC CARE LLC
Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Angiotech (Manan Medical Products, Inc.)
Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiratio…
Angiotech (Manan Medical Products, Inc.)
Portex Unit Dose 15 ml Normal Saline ¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to su…
Becton, Dickinson and Company, BD Biosciences
Medline Prefilled 550 ml Sterile¿¿ ¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoa…
Abbott Ireland Diagnostics Division
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specifi…
Handpiece Headquarters
MEDTRONIC CARELINK 2090 programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 3…
Radiometer America Inc
J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Angiotech (Manan Medical Products, Inc.)
BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard …
Bard Medical Division
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Arjohuntleigh Magog
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Angiotech (Manan Medical Products, Inc.)
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
Angiotech (Manan Medical Products, Inc.)
Naera Hospital Bassinet, Model No. 4402
Stryker Medical Division of Stryker Corporation
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applic…
GE Healthcare, LLC
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A30…
Bard Medical Division
Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory…
Haemonetics Corporation
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a…
Edwards Lifesciences, LLC
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica …
Siemens Healthcare Diagnostics, Inc.
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a …
GE Healthcare, LLC
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica S…
Siemens Healthcare Diagnostics, Inc.
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool…
Edwards Lifesciences, LLC
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
Wilson-Cook Medical Inc.
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion syst…
Medtronic Perfusion Systems
Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinit…
Abbott Gmbh & Co. KG
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
Wilson-Cook Medical Inc.
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic too…
Edwards Lifesciences, LLC
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy pro…
Riverpoint Medical, LLC
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for …
Siemens Healthcare Diagnostics, Inc.
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic to…
Edwards Lifesciences, LLC
3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patient…
3M Company - Health Care Business
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
WEST PHARMA. SERVICES IL, LTD
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
WEST PHARMA. SERVICES IL, LTD
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.