Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 recalls
Recalls in Medical Devices
Newest first · Page 11 of 810
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Civco Medical Instruments Co. Inc.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expan…
Mentor Texas, LP.
MiniMed 620G Insulin Pump (MMT-1750)
Medtronic MiniMed, Inc.
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Synthes (USA) Products LLC
BD Kiestra" ReadA; Catalog No.: 446948.
BD KIESTRA LAB AUTOMATION
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Civco Medical Instruments Co. Inc.
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Airway Exam Kit, DYKE1796
Medline Industries, LP
Paradigm Insulin Pump (MMT-712, MMT-715)
Medtronic MiniMed, Inc.
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Civco Medical Instruments Co. Inc.
Azurion 5 M12; System Code: (1)722227, (2)722231;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Oxoid Australia Pty Limited
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Civco Medical Instruments Co. Inc.
Burlington Medical, Half Aprons.
Burlington Medical, LLC
Burlington Medical, Vest
Burlington Medical, LLC
MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Medtronic MiniMed, Inc.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code:…
Abiomed, Inc.
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS conta…
Olympus Corporation of the Americas
Burlington Medical, Demi Half Aprons.
Burlington Medical, LLC
ALLURA Xper FD10F; System Code: 722002;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Siemens Healthcare Diagnostics, Inc.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450…
Mentor Texas, LP.
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
Medtronic MiniMed, Inc.
Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
Medline Industries, LP
Burlington Medical, Kilt Blockers.
Burlington Medical, LLC
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding produc…
Abiomed, Inc.
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3.…
Medline Industries, LP
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Mentor Texas, LP.
Allura Xper FD20/10; System Code: 722029;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tiss…
Mentor Texas, LP.
Burlington Medical, Protective Sleeves.
Burlington Medical, LLC
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 S…
Intuitive Surgical, Inc.
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Medline Industries, LP
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
Civco Medical Instruments Co. Inc.
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description:…
ReCor Medical Inc.
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PA…
Medline Industries, LP
Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
Ultradent Products, Inc.
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
Medtronic MiniMed, Inc.
Burlington Medical, Frontal Aprons
Burlington Medical, LLC
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Medtronic MiniMed, Inc.
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Medtronic MiniMed, Inc.
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reflexion Medical, Inc.
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Medtronic MiniMed, Inc.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth…
Mentor Texas, LP.
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics, 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 Jun 3, 2026.
Read our methodology — how this data is sourced, computed, and verified.
