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 157 of 808
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
Stryker Medical Division of Stryker Corporation
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
Heartware, Inc.
G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
Thor Photomedicine Ltd
ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
Stryker Medical Division of Stryker Corporation
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
AURIS HEALTH INC
NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
Thor Photomedicine Ltd
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Staar Surgical Company
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Staar Surgical Company
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Heartware, Inc.
Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
Integra LifeSciences Corp.
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
Integra LifeSciences Corp.
RANDOX Total Bilirubin.
Randox Laboratories Ltd.
ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
Stryker Medical Division of Stryker Corporation
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Vyaire Medical
ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
Stryker Medical Division of Stryker Corporation
ProCuity bed series, model number 3009, item number: 300900000000,
Stryker Medical Division of Stryker Corporation
Remington MEDICAL Drainage Bag, REF 600-D;
Remington Medical, Inc.
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIG…
Luminex Corporation
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Abiomed, Inc.
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon di…
Ortho-Clinical Diagnostics, INc.
Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
Integra LifeSciences Corp.
ProCuity bed series, model number 3009, item number: 3009PX-L-200
Stryker Medical Division of Stryker Corporation
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Staar Surgical Company
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bott…
Apotex Corp.
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 6042…
Golden State Medical Supply Inc.
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count…
Apotex Corp.
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 6042…
Golden State Medical Supply Inc.
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured …
Apotex Corp.
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apot…
Golden State Medical Supply Inc.
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L…
Apotex Corp.
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Intuitive Surgical, Inc.
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
PATH
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Medtronic Inc.
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended …
Breas Medical, Inc.
Lugol s Iodine Solution 500ML, Part Number 624-71
EMD Millipore Corporation
RAPIDPOINT 500 Blood Gas System
Siemens Healthcare Diagnostics Inc
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
PATH
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
PATH
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd.
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Becton Dickinson Infusion Therapy Systems Inc.
RAPIDPOINT 500e Blood Gas System
Siemens Healthcare Diagnostics Inc
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Aizu Olympus Co., Ltd.
Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Edwards Lifesciences, LLC
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase ch…
Abbott Molecular, Inc.
TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2:…
Edwards Lifesciences, LLC
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Edwards Lifesciences, LLC
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.