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 · 2026-09-02
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 714 of 822
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device …
Codman & Shurtleff, Inc.
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Gambro Renal Products, Incorporated
Double Offset Rasp Handle, Left Hand Nonsterile
Zimmer, Inc.
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Tim…
Medtronic MiniMed Inc.
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician wi…
AGFA Healthcare Corp.
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 …
AGFA Healthcare Corp.
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant in…
Codman & Shurtleff, Inc.
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all requ…
Nanosphere, Inc.
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene…
Nanosphere, Inc.
Double Offset Rasp Handle, Left Hand Nonsterile
Zimmer, Inc.
Double Offset Rasp Handle, Left Hand Nonsterile
Zimmer, Inc.
Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is …
Codman & Shurtleff, Inc.
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Zimmer, Inc.
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immun…
ORTHO-CLINICAL DIAGNOSTICS
DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Syst…
AGFA Healthcare Corp.
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodal…
Philips Medical Systems (Cleveland) Inc
VI DBL OFFST W/ LRG STPL, LT Nonsterile
Zimmer, Inc.
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Prog…
Codman & Shurtleff, Inc.
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Gambro Renal Products, Incorporated
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) Th…
Integra LifeSciences Corp.
Double Offset Rasp Handle, Left Hand Nonsterile
Zimmer, Inc.
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin…
BioMerieux SA
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device …
Codman & Shurtleff, Inc.
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
Zimmer, Inc.
Double Offset Rasp Handle, Right Hand Nonsterile
Zimmer, Inc.
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: E…
Enhancement Medical, LLC
Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral h…
Zimmer, Inc.
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Biosound Esaote, Inc.
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive …
Beevers Manufacturing & Supply, Inc.
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda…
Medtronic Neuromodulation
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
Zimmer, Inc.
VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemist…
Ortho-Clinical Diagnostics
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in…
Nanosphere, Inc.
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be…
Intuitive Surgical, Inc.
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
Zimmer, Inc.
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed o…
Carestream Health, Inc.
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical proc…
Nidek Inc
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an…
Codman & Shurtleff, Inc.
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinat…
Medical Positioning Inc
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantabl…
Codman & Shurtleff, Inc.
Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used…
Medical Positioning Inc
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cas…
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applicatio…
Siemens Medical Solutions USA, 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.