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 · 2026-08-22
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 465 of 819
Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
COVIDIEN MEDTRONIC
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, packaged 1/box,…
Cardinal Health 200, LLC
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Cardinal Health 200, LLC
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059…
Philips Medical Systems (Cleveland) Inc
Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and cl…
Hitachi Medical Systems America Inc
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case, single us…
Cardinal Health 200, LLC
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Pa…
Medtronic Navigation, Inc.
VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 …
Maquet SAS
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM
COVIDIEN MEDTRONIC
Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
COVIDIEN MEDTRONIC
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box,…
Cardinal Health 200, LLC
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile. .
Cardinal Health 200, LLC
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Edwards Lifesciences, LLC
PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
Ethicon, Inc.
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150…
NewDeal SA
UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
NewDeal SA
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A…
Medtronic Neuromodulation
ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
NewDeal SA
PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
Ethicon, Inc.
Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine g…
Cardinal Health 200, LLC
Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM
COVIDIEN MEDTRONIC
Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
COVIDIEN MEDTRONIC
MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 1…
Canadian Hospital Specialties
Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM
COVIDIEN MEDTRONIC
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.
Tandem Diabetes Care Inc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Cardinal Health 200, LLC
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Cardinal Health 200, LLC
Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlo…
Cardinal Health 200, LLC
PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
Ethicon, Inc.
AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a c…
Opgen Inc
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
Ethicon, Inc.
PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
Ethicon, Inc.
PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
Ethicon, Inc.
Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
COVIDIEN MEDTRONIC
PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
Ethicon, Inc.
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of pat…
Fx Solutions
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Cardinal Health 200, LLC
Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM
COVIDIEN MEDTRONIC
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display …
Intel-GE Care Innovations LLC
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (R…
RAYSEARCH LABORATORIES AB
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Siemens Healthcare Diagnostics, Inc.
Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
COVIDIEN MEDTRONIC
Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT
COVIDIEN MEDTRONIC
Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 11…
NewDeal SA
PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
Ethicon, Inc.
Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
Siemens Healthcare Diagnostics, Inc.
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis Sy…
AESDEX
Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/ca…
Cardinal Health 200, LLC
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
Ethicon, Inc.
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorh…
Cardinal Health 200, 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.