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 120 of 808
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Fresenius Medical Care Holdings, Inc.
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
American Contract Systems Inc
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
American Contract Systems Inc
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Fresenius Medical Care Holdings, Inc.
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
American Contract Systems Inc
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, trea…
Pivotal Health Solutions, Inc.
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
American Contract Systems Inc
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
American Contract Systems Inc
Pink Luminous Breast, Breast transilluminator
Silkprousa LLC
ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
American Contract Systems Inc
Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
MICROspecialties, Inc.
Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
MICROspecialties, Inc.
Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number …
Cardinal Health 200, LLC
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
American Contract Systems Inc
BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injection (eye)
Synergetics Inc
TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
American Contract Systems Inc
FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
American Contract Systems Inc
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Fresenius Medical Care Holdings, Inc.
Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
MICROspecialties, Inc.
TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
American Contract Systems Inc
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
American Contract Systems Inc
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRA…
Cardinal Health 200, LLC
Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
MICROspecialties, Inc.
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Fresenius Medical Care Holdings, Inc.
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
American Contract Systems Inc
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
American Contract Systems Inc
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
American Contract Systems Inc
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
American Contract Systems Inc
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat ir…
Zoll Medical Corporation
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting…
Maquet Cardiovascular, LLC
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
GE Vingmed Ultrasound As
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
American Contract Systems Inc
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Integra LifeSciences Corp.
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but n…
Siemens AG/Siemens Healthcare GmbH
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kel…
MEDLINE INDUSTRIES, LP - Northfield
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but n…
Siemens AG/Siemens Healthcare GmbH
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1H…
CareFusion 303, Inc.
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catal…
Megadyne Medical Products, Inc.
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040…
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Bl…
SEASPINE ORTHOPEDICS CORPORATION
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1F…
CareFusion 303, Inc.
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
First Source Inc
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter, Inc.
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kel…
MEDLINE INDUSTRIES, LP - Northfield
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned af…
Stryker Corporation
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of…
Nalu Medical, Inc.
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrat…
Ortho-Clinical Diagnostics, Inc.
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
CareFusion 303, Inc.
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Abbott Medical
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Angiodynamics, 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 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.