Product category · Updated Aug 19, 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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
41,070 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-29
Do more recalls mean more Class I danger?
Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 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 178 of 822
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 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
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 Balls
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 surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, gra
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: v3, v4, v5, and v6
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) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
Smiths Medical ASD Inc.
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
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) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS C
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 depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
Flower Orthopedics Corporation
Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Mod
Cardinal Health 200, LLC
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Fresenius Medical Care Holdings, 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 Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.