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 329 of 819
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individu…
Linet Americas
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro dia…
Ortho Clinical Diagnostics
NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly tha…
Arrow International Inc
Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates …
Wright Medical Technology, Inc.
Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
Arrow International Inc
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstru…
Flower Orthopedics Corporation
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is…
Maquet Cardiovascular Us Sales, Llc
HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, Health…
HF Acquisition Co., LLC
Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconst…
Flower Orthopedics Corporation
VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagno…
Ortho Clinical Diagnostics
Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
Arrow International Inc
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in t…
Shanghai United Imaging Healthcare Co., Ltd.
Tibial knee prosthesis
Smith & Nephew, Inc.
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver…
Ion Beam Applications S.A.
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstru…
Flower Orthopedics Corporation
Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavit…
TELEFLEX MEDICAL INC
BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use de…
Boss Instruments, Ltd.
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connect…
Normand-Info S.A.S.U.
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
CareFusion 303, Inc.
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
CareFusion 303, Inc.
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
CareFusion 303, Inc.
Alaris Pump Module Model 8100
CareFusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
CareFusion 303, Inc.
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…
Siemens Medical Solutions USA, Inc
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomi…
Siemens Medical Solutions USA, Inc
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-par…
GE Healthcare, LLC
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.…
Covidien Llc
SUTUREFIX ULTRA Suture, Product number 72203855
Smith & Nephew, Inc.
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Mako Surgical Corporation
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-…
Siemens Medical Solutions USA, Inc
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
CareFusion 303, Inc.
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
CareFusion 303, Inc.
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Siemens Healthcare Diagnostics, Inc.
Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexib…
Boston Scientific Corporation
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
CareFusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
CareFusion 303, Inc.
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determ…
RANDOX LABORATORIES, LTD.
Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endo…
Medline Industries Inc
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
CareFusion 303, Inc.
Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-sty…
Sutter Medizintechnik GmbH
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the s…
Boston Scientific Corporation
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5…
Covidien Llc
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
CareFusion 303, Inc.
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray…
Siemens Medical Solutions USA, Inc
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Smiths Medical ASD Inc.
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determina…
RANDOX LABORATORIES, LTD.
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.