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 11 of 808
Burlington Medical, Wrap Aprons.
Burlington Medical, LLC
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra Hi…
Mentor Texas, LP.
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Medtronic MiniMed, Inc.
Burlington Medical, Leg Wraps.
Burlington Medical, LLC
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 S…
Intuitive Surgical, Inc.
Allura Xper FD20/15 OR Table; System Code: 722059;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
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.