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 720 of 822
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Siemens Healthcare Diagnostics, Inc.
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Blue Belt Technologies MN
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to…
Claymount Assembli
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of …
Zimmer, Inc.
McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Med…
Medical Action Industries Inc
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drai…
Medtronic Neurosurgery
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-190…
Ventlab LLC
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of …
Zimmer, Inc.
Big Fireworks Recalls Mock Sword Fireworks Devices Due to Impact, Burn Hazards
American Eagle dba Big Fireworks, of Lansing, Mich.
ANSPACH***REF 98-0033***Custom Autolube Food Guard***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-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1…
NxStage Medical, Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient popu…
Beckman Coulter Inc.
ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clini…
Beckman Coulter Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 C…
NxStage Medical, Inc.
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy…
Zynex Medical, Inc.
ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***Custom QD11 Attachment with thinner nose tube***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, 150 CM Length M…
Nitinol Devices and Components, Inc.
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Western / Scott Fetzer Company
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
Stryker Endoscopy
ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support a…
Nellcor Puritan Bennett Inc. (dba Covidien LP)
ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized …
Integra LifeSciences Corp.
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
JAS Diagnostics Inc.
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
Beckman Coulter Inc.
ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspac…
The Anspach Effort, Inc.
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laborator…
Siemens Healthcare Diagnostics, Inc.
ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Syst…
The Anspach Effort, Inc.
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by…
Nitinol Devices and Components, Inc.
ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach…
The Anspach Effort, Inc.
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying …
SeaSpine Inc
Ingenia 3.0T, magnetic resonance imaging system.
Philips Medical Systems, Inc.
ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach S…
The Anspach Effort, Inc.
ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be…
The Anspach Effort, Inc.
ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 …
Siemens Healthcare Diagnostics, Inc
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-325…
SteriGear, LLC
ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Ingenia 3.0T R5, magnetic resonance imaging system.
Philips Medical Systems, Inc.
ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended…
The Anspach Effort, Inc.
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***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.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.03…
Nitinol Devices and Components, Inc.
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, 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.