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
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
40,910 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · NHTSA federal recall filings · 2026-08-26
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 549 of 819
Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
Resource Optimization & Innovation Llc
Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
Resource Optimization & Innovation Llc
Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
Resource Optimization & Innovation Llc
Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
Resource Optimization & Innovation Llc
Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn
Resource Optimization & Innovation Llc
SynchroMed II implantable drug infusion pump, Model 8637-40,
Medtronic Neuromodulation
Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa
Resource Optimization & Innovation Llc
Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU
Resource Optimization & Innovation Llc
Proteus 235
Ion Beam Applications S.A.
Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
Resource Optimization & Innovation Llc
Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Childrens Santa Rosa
Resource Optimization & Innovation Llc
Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa
Resource Optimization & Innovation Llc
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Focus Diagnostics Inc
Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills
Resource Optimization & Innovation Llc
Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
Resource Optimization & Innovation Llc
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Zimmer Biomet, Inc.
Merge Cardio software.
Merge Healthcare, Inc.
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobi…
BioMerieux SA
Poly Component Trial, UCCS, packaged in the following sizes and configurations: a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 b) Poly Comp Tr…
Medtronic Sofamor Danek USA Inc
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the anti…
BioMerieux SA
Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who ar…
Ohmeda Medical
PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gl…
Purewick Corporation
Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to n…
Ohmeda Medical
CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their …
Ohmeda Medical
ONCOR" Avant-garde
Siemens Medical Solutions USA, Inc
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation…
Siemens Healthcare Diagnostics, Inc.
Hitachi Echelon MRI System
Hitachi Medical Systems America Inc
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warm…
Ohmeda Medical
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicro…
BioMerieux SA
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
Panta Nail, Rx only, Sterile,
Integra LifeSciences Corp.
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables reside…
Stanley Security Solutions Inc
Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to …
Ohmeda Medical
Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated…
Ohmeda Medical
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETB…
Medtronic Vascular, Inc.
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Siemens Medical Solutions USA, Inc
Hitachi Oasis MRI System
Hitachi Medical Systems America Inc
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Haag-Streit USA Inc
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, Inc.
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicr…
BioMerieux SA
Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hy…
Ohmeda Medical
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Merge Healthcare, Inc.
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antim…
BioMerieux SA
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobi…
BioMerieux SA
ARTIS Q, Interventional Fluroscopic x-ray system
Siemens Medical Solutions USA, Inc
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical inf…
Merge Healthcare, Inc.
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to displ…
Siemens Medical Solutions USA, Inc
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient…
Medical Components, Inc dba MedComp
Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-…
Ohmeda Medical
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Crossroads Extremity Systems 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 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.