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 213 of 819
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
Bolton Medical Inc.
Vasoshield Syringe Packs, Model VH-5001
Maquet Cardiovascular, LLC
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35…
Datascope Corp.
Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211
Cardinal Health 200, LLC
Hemopro 2 with Vasoshield, Model VH-4001
Maquet Cardiovascular, LLC
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
Cardinal Health 200, LLC
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used…
Cardiac Assist, Inc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
Cardinal Health 200, LLC
AXIOM Luminos Agile
Siemens Medical Solutions USA, Inc
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210
Cardinal Health 200, LLC
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
Cardinal Health 200, LLC
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF
Siemens Medical Solutions USA, Inc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215
Cardinal Health 200, LLC
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83…
Datascope Corp.
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188
Cardinal Health 200, LLC
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260,…
Philips Respironics, Inc.
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Stradis Healthcare
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Stradis Healthcare
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Stradis Healthcare
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Medtronic Neuromodulation
Pediatric Craniotome Ref:CRANI-P-G1
The Anspach Effort, Inc.
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Covidien, LLC
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Stradis Healthcare
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Stradis Healthcare
cobas infinity central lab, Material Number 07154003001
Roche Diagnostics Operations, Inc.
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
The Anspach Effort, Inc.
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the q…
Siemens Healthcare Diagnostics, Inc.
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone i…
The Anspach Effort, Inc.
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Stradis Healthcare
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Stradis Healthcare
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
CoreLink LLC
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Stradis Healthcare
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Stradis Healthcare
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Stradis Healthcare
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
Medtronic Neuromodulation
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 88881351…
Covidien LP
RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from t…
Emergent Protective Products USA Inc
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
Medtronic Neuromodulation
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Integra LifeSciences Corp.
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone includin…
The Anspach Effort, Inc.
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pa…
Stradis Healthcare
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Stradis Healthcare
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.