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 409 of 819
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Monarch Medical Technologies
Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 HPK1A
Arrow International Inc
Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 HPK1A
Arrow International Inc
CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is compr…
Med Tec Inc
Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A
Arrow International Inc
Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
Arrow International Inc
Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
Arrow International Inc
ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intende…
Ethicon, Inc.
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging an…
GE Healthcare, LLC
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Arrow International Inc
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Covidien LLC
Arrow PICC Kit Product Code: ASK 45552 RWJ4
Arrow International Inc
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Covidien LLC
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Covidien LLC
Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A
Arrow International Inc
EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
Covidien LLC
Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44063 VPS2
Arrow International Inc
Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 VPS2
Arrow International Inc
SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
Covidien LLC
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
Teleflex Medical
Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA
Arrow International Inc
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Teleflex Medical
Arrowg+ard Blue Advance" PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45041 VPS2
Arrow International Inc
SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
Covidien LLC
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vsc…
GE Healthcare, LLC
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) im…
GE Healthcare, LLC
Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET…
GE Healthcare, LLC
Arrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM
Arrow International Inc
Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45541 HPHNL
Arrow International Inc
Arrow¿ PICC with Chlorag+ard Technology Product Code: CDC 44052 HPK1A
Arrow International Inc
EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
Covidien LLC
Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM
Arrow International Inc
Cepheid Xpert C. difficile/Epi Control Panel
Microbiologics Inc
Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
Arrow International Inc
Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A
Arrow International Inc
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended …
Ethicon, Inc.
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of t…
Cytocell Ltd.
Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM
Arrow International Inc
Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
Arrow International Inc
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Covidien LLC
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Mako Surgical Corporation
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24…
Cook Inc.
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) No…
Teleflex Medical
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The A…
Cook Inc.
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Adv…
Cook Inc.
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Co…
Teleflex Medical
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Adv…
Cook Inc.
Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) im…
GE Healthcare, LLC
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Stryker GmbH
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS…
Zimmer Biomet, 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.