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 721 of 822
ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
MAS Omni Immune PRO Controls
Microgenics Corporation
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexe…
BioFire Diagnostics, Inc.
Ingenia 1.5T, magnetic resonance imaging system.
Philips Medical Systems, Inc.
ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Syst…
The Anspach Effort, Inc.
ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach…
The Anspach Effort, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Intuitive Surgical, Inc.
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model number…
Steris Corporation
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibrat…
Siemens Healthcare Diagnostics, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Ma…
Nitinol Devices and Components, Inc.
Ingenia 1.5T R5, magnetic resonance imaging system.
Philips Medical Systems, Inc.
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to …
Siemens Medical Solutions USA, Inc
ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach…
The Anspach Effort, Inc.
ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic…
Siemens Medical Solutions USA, Inc
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, …
NxStage Medical, Inc.
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, t…
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manuf…
Nitinol Devices and Components, Inc.
ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses …
Biomet, Inc.
VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Zimmer, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, …
NxStage Medical, Inc.
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides me…
Nidek Inc
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, …
NxStage Medical, Inc.
HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufa…
Nitinol Devices and Components, Inc.
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Intuitive Surgical, Inc.
ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray …
Philips Medical Systems (Cleveland) Inc
MAS Omni Immune Controls
Microgenics Corporation
ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspach Syst…
The Anspach Effort, Inc.
ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Man…
Nitinol Devices and Components, Inc.
ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m…
NxStage Medical, Inc.
ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manu…
Nitinol Devices and Components, Inc.
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Baxter Corporation Englewood
HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; Manufa…
Nitinol Devices and Components, Inc.
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended f…
Alere San Diego, Inc.
Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare p…
Spacelabs Healthcare Inc
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, …
NxStage Medical, Inc.
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Ma…
Nitinol Devices and Components, Inc.
ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length M…
Nitinol Devices and Components, Inc.
ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and M…
LAP of America Laser Applications, 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 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.