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 297 of 819
In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
In2Bones, SAS
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycop…
Meridian Bioscience Inc
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubatio…
TELEFLEX MEDICAL INC
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head …
Corin Ltd
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (G…
Corin Ltd
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 -…
Biosense Webster, Inc.
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including…
Siemens Medical Solutions USA, Inc
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation
S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good…
Stryker Communications
VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, …
Biomerieux Inc
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
RAYSEARCH LABORATORIES AB
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient d…
Mizuho OSI
Operating Table System
Getinge Group Logistics America, LLC
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultras…
Hitachi Medical Systems America Inc
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuou…
Baxter Healthcare Corporation
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 …
Biosense Webster, Inc.
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from …
TELEFLEX MEDICAL INC
In-View Clear Leggings Sterile Non-Sterile
Cardinal Health 200, LLC
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label…
Bard Peripheral Vascular Inc
Femoral Angiography Drape Bulk Non-Sterile
Cardinal Health 200, LLC
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) i…
CAIRE DIAGNOSTICS INC
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicr…
Biomerieux Inc
Femoral Angiography Drape Sterile
Cardinal Health 200, LLC
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare Corporation
In-View Clear Leggings Bulk Non-Sterile
Cardinal Health 200, LLC
Inyo Pool Products Recalls PureLine Pool Pump Motors Due to Fire Hazard; Sold Exclusively on inyopools.com (Recall Alert)
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dol…
Edge Pharma, LLC
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITRO…
Ortho-Clinical Diagnostics, Inc.
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tu…
Accuray Incorporated
JUDKINS PACK
Cardinal Health 200, LLC
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited…
Epimed International, Inc.
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a c…
Medline Industries Inc
McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of…
Cardinal Health 200, LLC
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pac…
Ortho-Clinical Diagnostics, Inc.
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Sirtex Medical Limited
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdr…
Cardinal Health 200, LLC
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) wi…
Medtronic Perfusion Systems
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosur…
Medtronic Perfusion Systems
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Siemens Healthcare Diagnostics, Inc
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or …
CARESTREAM DENTAL, LLC
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance …
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a si…
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-u…
Medtronic Perfusion Systems
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface i…
Medtronic Perfusion Systems
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE…
Medtronic Perfusion Systems
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comp…
Merit Medical Systems, Inc.
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, pa…
Cardinal Health 200, LLC
Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following sof…
Mindray DS USA, Inc. dba Mindray North America
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use d…
Medtronic Perfusion Systems
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.