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 151 of 808
Calibration Serum Level 3 CAL2351
Randox Laboratories Ltd.
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
Getinge Usa Sales Inc
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD5675019…
Getinge Usa Sales Inc
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD5677030…
Getinge Usa Sales Inc
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Getinge Usa Sales Inc
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Smiths Medical Asd Inc
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Olympus Corporation of the Americas
Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10…
Getinge Usa Sales Inc
regard Operative LAP, Item Number 800943001; surgical convenience kit
ROi CPS LLC
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Percussionaire Corporation
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Philips North America
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Maquet Cardiovascular, LLC
Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 40…
Getinge Usa Sales Inc
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
Oakworks Inc
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table
Oakworks Inc
6IN PRESSURE TUBING, List Number MX20617
Smiths Medical Asd Inc
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Maquet Cardiovascular, LLC
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Globus Medical, Inc.
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended for use in the noninvasiv…
Xcision Medical Systems, LLC
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/…
Limacorporate S.p.A
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a crico…
Sarnova HC, Llc
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
PHASE SCIENTIFIC INTERNATIONAL LIMITED
Medex LOGICAL CATH LAB KIT, List Number M20754
Smiths Medical Asd Inc
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Olympus Corporation of the Americas
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
Smiths Medical Asd Inc
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Randox Laboratories Ltd.
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Philips North America Llc
Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD Q…
Getinge Usa Sales Inc
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
Smiths Medical Asd Inc
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
Oakworks Inc
TECNIS Toric II OptiBlue IOL Models ZCW
Johnson & Johnson Surgical Vision, Inc.
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
Becton Dickinson & Company
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
Abbott Diabetes Care, Inc.
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
Shirakawa Olympus Co., Ltd.
Sensis Vibe Hemo
Siemens Medical Solutions USA, Inc
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation eq…
Olympus Corporation of the Americas
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power ch…
mo-Vis BVBA
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the …
Abiomed, Inc.
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code …
Baxter Healthcare Corporation
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. …
Abiomed, Inc.
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Baxter Healthcare Corporation
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FIL…
BioFire Diagnostics, LLC
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Townsend Design
QMS Tacrolimus Calibrators, Product code 10015573
Ortho-Clinical Diagnostics, Inc.
VADER pedicle system, torque wrench, Catalog Number 42-702
Icotec Ag
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
Shirakawa Olympus Co., Ltd.
BrightView X, Gamma Camera, Product Code 882478
Philips North America
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Philips North America
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Blue Belt Technologies, Inc
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuo…
Abbott Laboratories
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.