Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 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 164 of 808
PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
Universal Meditech Inc.
Pediatric Urology Wolson Pack, REF BPPU55A
American Contract Systems, Inc.
General Pack, REF BBGP31C
American Contract Systems, Inc.
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Preat Corp
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
Universal Meditech Inc.
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
GE Healthcare
PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
Universal Meditech Inc.
Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
Medtronic Sofamor Danek USA Inc
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Pine Pharmaceuticals, LLC
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Olympus Corporation of the Americas
SenSight Connector Plug, Model Number B31061.
Medtronic Neuromodulation
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Tornier, Inc
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
EITAN MEDICAL LTD
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Cardinal Health 200, LLC
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
MEDLINE INDUSTRIES, LP - Northfield
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Access Vascular, Inc
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Access Vascular, Inc
Functional MR V1.0
OLEA MEDICAL
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
DeRoyal Industries Inc
MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
MEDLINE INDUSTRIES, LP - Northfield
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654…
North Coast Medical Inc
MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
MEDLINE INDUSTRIES, LP - Northfield
Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
Cardinal Health 200, LLC
Multichem P, Part Code 08P90-10
TECHNO-PATH MANUFACTURING LTD.
MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
Mazor Robotics Ltd
Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
Cardinal Health 200, LLC
2008T HD SYS. W/O CDX BLUESTAR
Fresenius Medical Care Holdings, Inc.
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Encore Medical, LP
Constellation Vision System, REF: 8065751150
Alcon Research, LLC
2008T Hemodialysis SYS, with CDX
Fresenius Medical Care Holdings, Inc.
CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe Therapy…
RoyalVibe Health Ltd.
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Ansell Healthcare Products LLC
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surg…
Olympus Corporation of the Americas
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions…
Smiths Medical ASD Inc.
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Fresenius Medical Care Holdings, Inc.
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0…
Smiths Medical ASD Inc.
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMO…
Cardinal Health 200, LLC
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Preso…
Cardinal Health 200, LLC
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
TECHNO-PATH MANUFACTURING LTD.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Fresenius Medical Care Holdings, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Beckman Coulter, Inc.
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Smiths Medical ASD Inc.
MED-810A Zemits NDPrime Laser products
Advance-Esthetic LLC
3T Heater Cooler System, REF: 16-02-85
LivaNova Deutschland GmbH
Access Thyroglobulin Calibrators
Beckman Coulter, Inc.
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate dep…
Flower Orthopedics Corporation
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP2…
Cardinal Health 200, 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
- 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 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.