Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 51 of 810
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL ar…
THOR Photomedicine Ltd
STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and …
Diagnostica Stago, Inc.
S4-1 Transducer Probe
Philips Ultrasound, Inc
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and N…
THOR Photomedicine Ltd
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/IT…
American Contract Systems Inc
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are i…
THOR Photomedicine Ltd
c5-1 Transducer Probe
Philips Ultrasound, Inc
V6-2 Transducer Probe
Philips Ultrasound, Inc
C9-4 Transducer Probe
Philips Ultrasound, Inc
L12-5 50 Transducer Probe
Philips Ultrasound, Inc
V9-2 Transducer Probe
Philips Ultrasound, Inc
XL14-3 Transducer Probe
Philips Ultrasound, Inc
X8-2t Transducer Probe
Philips Ultrasound, Inc
C9-3io Transducer Probe
Philips Ultrasound, Inc
L11-3 Transducer Probe
Philips Ultrasound, Inc
OMNI III TEE Transducer Probe
Philips Ultrasound, Inc
Orascoptic Superior Visualization Custom loupes with Dragonfly frames
Orascoptic Surgical Acuity
D2TCD Transducer Probe
Philips Ultrasound, Inc
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Onkos Surgical, Inc.
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tr…
C.R. Bard Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BU…
American Contract Systems Inc
C5-2 Transducer Probe
Philips Ultrasound, Inc
L15-7IO TRANSDUCER Transducer Probe
Philips Ultrasound, Inc
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Onkos Surgical, Inc.
X7-2t Transducer Probe
Philips Ultrasound, Inc
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Onkos Surgical, Inc.
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
Orascoptic Surgical Acuity
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/I…
American Contract Systems Inc
L17-5 Transducer Probe
Philips Ultrasound, Inc
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
VANTIVE US HEALTHCARE LLC
C10-3v Transducer Probe
Philips Ultrasound, Inc
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Orascoptic Surgical Acuity
C9-5ec Transducer Probe
Philips Ultrasound, Inc
S8-3 Transducer Probe
Philips Ultrasound, Inc
S12-4 Transducer Probe
Philips Ultrasound, Inc
S7-2t Transducer Probe
Philips Ultrasound, Inc
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 108854…
CareFusion 303, Inc.
X3-1 Transducer Probe
Philips Ultrasound, Inc
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop …
Drs Vascular, Inc
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. …
Olympus Corporation of the Americas
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the S…
Boston Scientific Neuromodulation Corporation
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Mckesson Medical-Surgical Inc. Corporate Office
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, work…
Spiggle & Theis Mt Gmbh
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, …
Boston Scientific Corporation
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658…
Boston Scientific Corporation
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Pentax of America Inc
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporizati…
LUMENIS, LTD.
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical …
Olympus Corporation of the Americas
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure v…
Hamilton Medical AG
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Ortho-Clinical Diagnostics, 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 Jun 3, 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 Jun 3, 2026.