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 321 of 819
SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets an…
ICU Medical, Inc.
TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
Smith & Nephew, Inc.
124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouche…
ICU Medical, Inc.
148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101…
ICU Medical, Inc.
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)006304145991…
Siemens Healthcare Diagnostics, Inc
112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)1088770908…
ICU Medical, Inc.
54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administratio…
ICU Medical, Inc.
5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multiv…
ICU Medical, Inc.
11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101…
ICU Medical, Inc.
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent …
GE Healthcare, LLC
112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17…
ICU Medical, Inc.
7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch…
ICU Medical, Inc.
10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50…
ICU Medical, Inc.
128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac…
ICU Medical, Inc.
Schneider Electric Recalls Surgeloc™ Surge Protection Devices Due to Fire Hazard
Schneider Electric Systems USA, Inc., of Foxboro, Mass.
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used …
Getinge Group Logistics America, LLC
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human s…
Siemens Healthcare Diagnostics, Inc.
SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended…
Handicare AB
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
Albumin Gen.2, Catalog 05166861190
Roche Diagnostics Operations, Inc.
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum…
Siemens Healthcare Diagnostics, Inc.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. …
Biomet, Inc.
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho …
Mizuho OSI
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surge…
Alcon Research, LLC
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacu…
Genicon, Inc.
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended t…
Biomet, Inc.
Tina-quant Complement C4 ver.2, Catalog 05991994190
Roche Diagnostics Operations, Inc.
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07…
Gentian AS
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial co…
Fresenius Medical Care Holdings, Inc.
MediCult Vitrification Cooling Media, Model Number 12284001F
CooperSurgical, Inc.
SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit …
Skytron, Div. The KMW Group, Inc
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/…
Siemens Medical Solutions USA, Inc
Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigt…
Cook Inc.
Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an …
Cook Inc.
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone T…
Nuvasive Specialized Orthopedics Inc
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an…
Brainlab AG
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Siemens Medical Solutions USA, Inc.
DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibi…
Encore Medical, LP
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Biomet, Inc.
Quick Release Gait Belt, 60
Medline Industries Inc
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Model: VGDF-SK…
Skytron, Div. The KMW Group, Inc
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Biomet 3i, LLC
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Biomet, Inc.
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of an…
Medline Industries Inc
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combi…
Medline Industries Inc
Biomet Regenerex Primary Taper Cap Item Number 141269
Biomet, Inc.
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combi…
Medline Industries Inc
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any co…
Medline Industries Inc
CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
Biomet 3i, LLC
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transl…
Bard Peripheral Vascular Inc
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.