Product category · Updated Jul 29, 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 (40,910 notices, 39.3% of the archive); 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. Among 12 product categories, that is #1 of 12. 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
- #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 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
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 355 of 819
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Philips North America, LLC
Poly G Integris H5000, System code 72246
Philips North America, LLC
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed…
TeDan Surgical Innovations LLC
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
The Binding Site Group, Ltd.
TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Materialise N.V.
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to p…
Arthrex, Inc.
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN07…
Aesculap Implant Systems LLC
D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products …
TeDan Surgical Innovations LLC
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR0…
Aesculap Implant Systems LLC
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (IC…
Boston Scientific Corporation
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
Allura CV20, system code 722031
Philips North America, LLC
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed…
TeDan Surgical Innovations LLC
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 …
Philips North America, LLC
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Smith & Nephew, Inc.
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products…
Stryker Corporation
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959…
Siemens Medical Solutions USA, Inc
C3 Manufacturing Recalls Perfect Descent Climbing Systems Climbing Belay Devices Due to Fall Hazard
C3 Manufacturing LLC, of Littleton, Colo.
Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Redline Pharmacy Solutions
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump Sy…
CME America, LLC
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The …
EHOB, Inc.
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vial…
Cardinal Health 200, LLC
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System …
Nextremity Solutions
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspirati…
Cardinal Health 200, LLC
Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796…
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
Verathon, Inc.
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
BioFire Diagnostics, LLC
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Maquet Cardiovascular Us Sales, Llc
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left v…
Heartware, Inc.
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral ner…
Integra LifeSciences Corp.
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Braemar Manufacturing, LLC
Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from via…
Cardinal Health 200, LLC
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refract…
Heartware, Inc.
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay …
The Binding Site Group, Ltd.
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: …
Response Biomedical Corp.
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B3…
Medicrea International
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Qiagen Sciences LLC
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Braemar Manufacturing, LLC
RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
RAYSEARCH LABORATORIES AB
Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injec…
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 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.