PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,910 recalls, about 39.3% of the federal recall archive, of which 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. 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
  • 39.3% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 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
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 188 of 819

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSF…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEI…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080

Abiomed, Inc.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJ…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

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-…

Datascope Corp.

FDA Devices Critical Jul 26, 2023

Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

Olympus Corporation of the Americas

FDA Devices Moderate Jul 26, 2023

Contour¿ next GEN Blood Glucose Monitoring System

Ascensia Diabetes Care US, Inc.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Datascope Corp.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b)…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Beckman Coulter Biomedical GmbH

FDA Devices Moderate Jul 26, 2023

Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplifi…

DiaSorin Molecular LLC

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Beckman Coulter Biomedical GmbH

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound pro…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILV…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLAT…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b)…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a…

Cytocell Ltd.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Mode…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

Aesculap Implant Systems LLC

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) P…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Mode…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patie…

Materialise N.V.

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b)…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Impella 2.5 intravascular micro axial blood pump, Product Number 005042

Abiomed, Inc.

FDA Devices Critical Jul 26, 2023

Impella CP intravascular micro axial blood pump, Product Number 0048-0032

Abiomed, Inc.

FDA Devices Moderate Jul 26, 2023

Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, …

Medtronic Neurosurgery

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to…

UFSK - International OSYS Gmbh

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE B…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, Model Number DT22065

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325; b) PPE …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

Cardinal Health 200, LLC

FDA Devices Critical Jul 26, 2023

Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150

Olympus Corporation of the Americas

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART L…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Jul 26, 2023

Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100

Abiomed, Inc.

FDA Devices Critical Jul 26, 2023

Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

Olympus Corporation of the Americas

FDA Devices Moderate Jul 26, 2023

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV S…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Jul 19, 2023

Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Jul 19, 2023

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Jul 19, 2023

REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

Osteomed, LLC

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

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.