PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

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

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
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 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 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 105 of 808

FDA Devices Moderate Sep 18, 2024

Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam i…

Hitachi America, Ltd., Particle Therapy Division

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) A…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

BioFire Diagnostics, LLC

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) I…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b)…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

25-LHP-828, HeNe Laser System, 35 mW

PACIFIC LASERTECH, LLC

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PR…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) P…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Numbe…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR &…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS,…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) U…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. …

Bard Peripheral Vascular Inc

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Sep 18, 2024

Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

Zoe Medical Incorporated

FDA Devices Moderate Sep 18, 2024

Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current …

Olympus Corporation of the Americas

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pac…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K;…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) EN…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines w…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Sep 18, 2024

ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOP…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SO…

Sol-Millennium Medical Inc.

FDA Devices Moderate Sep 18, 2024

Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A…

Sol-Millennium Medical Inc.

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam…

Hitachi America, Ltd., Particle Therapy Division

FDA Devices Moderate Sep 18, 2024

Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

Medtronic Xomed, Inc.

FDA Devices Moderate Sep 18, 2024

KIT PEDI CRANI LAMI, Pack Number DYNJ907372A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number D…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current …

Olympus Corporation of the Americas

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYK…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PACK , Pack Number DYNJ45158A ;…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Sep 18, 2024

Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B

MEDLINE INDUSTRIES, LP - Northfield

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 2, 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 2, 2026.