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 336 of 819
(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Mate…
Siemens Healthcare Diagnostics, Inc.
uCT 530 Computed Tomography X-Ray System
Shanghai United Imaging Healthcare Co., Ltd.
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Ortho Clinical Diagnostics
Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a labo…
Siemens Healthcare Diagnostics Inc.
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, n…
Radiometer Medical ApS
Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
LivaNova USA Inc.
Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
LivaNova USA Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; RE…
Westmed, Inc.
Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
LivaNova USA Inc.
ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near pa…
Radiometer Medical ApS
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Ortho Clinical Diagnostics
Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
LivaNova USA Inc.
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
LivaNova USA Inc.
R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08…
QuVa Pharma, Inc.
Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and …
PROVIDENCE MEDICAL TECHNOLOGIES
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental d…
Coltene Whaledent Inc
ADVIA Chemistry Calibrator
Siemens Healthcare Diagnostics, Inc.
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam…
Coltene Whaledent Inc
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Siemens Healthcare Diagnostics, Inc.
Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.…
Hocoma AG
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042…
GE Healthcare, LLC
Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vi…
Utak Laboratories Inc
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9…
RAYSEARCH LABORATORIES AB
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Tosoh Bioscience Inc
Oscar 2, Model 250 System
Suntech Medical, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is…
Merge Healthcare, Inc.
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Zest Anchors LLC
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental da…
Coltene Whaledent Inc
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Siemens Healthcare Diagnostics Inc
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Mevion Medical Systems, Inc.
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automati…
Argon Medical Devices, Inc
Atellica CH Chemistry Calibrator
Siemens Healthcare Diagnostics, Inc.
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Siemens Healthcare Diagnostics, Inc.
HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam …
Coltene Whaledent Inc
BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, s…
Angiodynamics, Inc.
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the te…
Stryker GmbH
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E246…
Defibtech, LLC
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
GE Healthcare, LLC
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quan…
Ortho-Clinical Diagnostics
BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous…
Angiodynamics, Inc.
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intende…
Stryker GmbH
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A10…
Defibtech, LLC
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use …
Medtronic Sofamor Danek USA Inc
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Biomet
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intende…
Stryker GmbH
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-us…
Medtronic Sofamor Danek USA Inc
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Diasol, Inc
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use …
Medtronic Sofamor Danek USA Inc
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling…
Resource Optimization & Innovation LLC
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixa…
Stryker GmbH
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.