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 285 of 819
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840…
GE Healthcare, LLC
VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS…
Bard Peripheral Vascular Inc
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Ossur Americas
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Circulatory Technology Inc.
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Radiometer Medical ApS
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 …
Anodyne Surgical
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who…
Covidien, LP
Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based el…
Abbott Laboratories Inc. (St Jude Medical)
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Medtronic Perfusion Systems
Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS…
Bard Peripheral Vascular Inc
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Abbott Laboratories Inc. (St Jude Medical)
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor…
Skytron, Div. The KMW Group, Inc
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Sur…
Windstone Medical Packaging, Inc.
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Radiometer Medical ApS
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patient…
Covidien, LP
Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardio…
Abbott Laboratories Inc. (St Jude Medical)
VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS…
Bard Peripheral Vascular Inc
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
Corin Ltd
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgic…
Windstone Medical Packaging, Inc.
ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
Johnson & Johnson Vision Care, Inc.
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with thi…
Medtronic Vascular
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Alphatec Spine, Inc.
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Avid Medical, Inc.
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The My…
Nico Corp.
Quanta System Sterile Optical Laser Fiber, reusable
Quanta System, S.p.A.
Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, Non-Sterile, UDI: (01)00190376268521
Alphatec Spine, Inc.
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Avid Medical, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-Level, 22 mm, Rx Only, Non-Sterile, UDI: (01)00190376268484
Alphatec Spine, 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.