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 261 of 819
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go…
Biomeme, Inc.
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box.…
Tapemark Company
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2…
Invacare Corporation
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20S…
Invacare Corporation
Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to fac…
Flower Orthopedics Corporation
Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic …
Siemens Healthcare Diagnostics, Inc.
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
DiaSorin Molecular LLC
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberromete…
AMO Manufacturing USA, LLC
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. M…
Siemens Medical Solutions USA, Inc
VIDAS RUB IgG (RBG), REF 30226
bioMerieux, Inc.
VIDAS FSH, REF 30407-01
bioMerieux, Inc.
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Abbott
VIDAS SARS-COV-2 IgM, Ref 423833-01
bioMerieux, Inc.
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
bioMerieux, Inc.
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPO…
Forbes Rehab Services Inc
VIDAS Estradiol II, REF 30431-01
bioMerieux, Inc.
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and pla…
Siemens Healthcare Diagnostics, Inc.
VIDAS Lyme IgG II (LYM), REF 417401
bioMerieux, Inc.
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System N…
AMO Manufacturing USA, LLC
VIDAS PRG Progesterone, REF 30409-01
bioMerieux, Inc.
VIDAS LH, REF 30406-01
bioMerieux, Inc.
VIDAS Measles IgG (MSG), REF 30219
bioMerieux, Inc.
VIDAS Clostridium Difficile GDH, REF 30125-01
bioMerieux, Inc.
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
bioMerieux, Inc.
VIDAS Lyme IgM II (LYM), REF 416436
bioMerieux, Inc.
VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
bioMerieux, Inc.
VIDAS Mumps IgG (MPG), REF 30218
bioMerieux, Inc.
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Biomerieux Inc
VIDAS SARS-COV-2 IgG, Ref 423834-01
bioMerieux, Inc.
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Medtronic Neuromodulation
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Migo Trading LLC
VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
bioMerieux, Inc.
Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/…
Karl Storz Endoscopy
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 38…
Intuitive Surgical, Inc.
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Coloplast Manufacturing US, LLC
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Produ…
Hill-Rom Inc.
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Civco Medical Instruments Co. Inc.
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Stradis Medical, LLC dba Stradis Healthcare
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Beaver Visitec International, Inc.
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Wright Medical Technology Inc
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Beckman Coulter Inc.
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguid…
Medtronic Navigation, Inc.
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Civco Medical Instruments Co. Inc.
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number…
Beaver Visitec International, Inc.
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Wright Medical Technology, 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 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.