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 64 of 808
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
AVID Medical, Inc.
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended …
Abbott Molecular, Inc.
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN M…
Cook Incorporated
Intera 1.0T Omni/Stellar, Model Number: 781102;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
AVID Medical, Inc.
Enterprise 1.5T, Model Number: 781145;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric s…
Richard Wolf GmbH
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLi…
Vyaire Medical
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction…
Abbott Molecular, Inc.
Intera 1.5T Omni/Stellar, Model Number: 781104;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 0.5T Standard, Model Number: 781101;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayT…
Klinika Mdical Gmb
Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm …
Meddev Corp
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Baxter Healthcare Corporation
Intera 3.0T Quasar Dual, Model Number: 781150;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Power/Pulsar, Model Number: 781105;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
Medical Depot Inc.
Intera 1.5T R11, Model Number: 781170;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
ICU Medical, Inc.
Intera 1.5T, Model Numbers: 781195 and 781295;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.0T Power/Pulsar, Model Number: 781103;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3010 Product Description: Contour Gold Eyelid Weight, 1.0 gm …
Meddev Corp
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
AVID Medical, Inc.
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
LeMaitre Vascular, Inc.
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 16…
LeMaitre Vascular, Inc.
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bott…
Nipro Renal Soultions USA, Corporation
Intera CV, Model Number: 781107;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is …
Augmedics Ltd.
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the…
Klinika Mdical Gmb
CMS8000 Patient Monitor
Contec Medical Systems Co., Ltd.
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) B…
Baxter Healthcare Corporation
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLi…
Vyaire Medical
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.
LeMaitre Vascular, Inc.
Centurion Sterile Weitlaner Retractor, Reorder: 67315
MEDLINE INDUSTRIES, LP - Northfield
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Ped…
Philips North America Llc
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PU…
Smiths Medical ASD, Inc.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Philips Medical Systems Nederland B.V.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Remote Diagnostic Technologies Ltd.
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation insti…
WANDERCRAFT SAS
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21…
Smiths Medical ASD, Inc.
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other intervent…
Galt Medical Corporation
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Integra LifeSciences Corp. (NeuroSciences)
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-…
Smiths Medical ASD, Inc.
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introd…
Galt Medical Corporation
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CAD…
Smiths Medical ASD, Inc.
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Integra LifeSciences Corp. (NeuroSciences)
Artix MT Thrombectomy Device, REF: 32-102
Inari Medical - Oak Canyon
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
MEDLINE INDUSTRIES, LP - Northfield
CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated…
Smiths Medical ASD, Inc.
Washer Disinfector Aquadis 56; Model Number: 56M
Getinge Disinfection Ab
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.