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 349 of 819
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Radiometer Medical ApS
CapsoCAM Plus, UDI: 00867770000209
Capso Vision, Inc.
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/29…
Medivators, Inc.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
ClearCanvas RIS/PACS
Synaptive Medical Inc
Olympus Pleuravideoscope, Model LTF-160
Olympus Corporation of the Americas
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
Boston Scientific
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
Boston Scientific
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along wit…
Medivators, Inc.
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympu…
Medivators, Inc.
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Carolina Liquid Chemistries Corp
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care set…
Radiometer Medical ApS
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Boston Scientific
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine …
Biomerieux Inc
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, …
Radiometer Medical ApS
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to reli…
Biomet, Inc.
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Boston Scientific
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
Smith & Nephew, Inc.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-5…
Radiometer Medical ApS
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., w…
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUE…
Fresenius Medical Care Holdings, Inc.
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Acutus Medical Inc
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Abbott Gmbh & Co. KG
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endost…
Medivators, Inc.
ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Johnson & Johnson Vision Care, Inc.
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Sys…
Beckman Coulter Inc.
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Boston Scientific
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
Boston Scientific
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
Acutus Medical Inc
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to co…
Rayner Intraocular Lenses Limited
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160…
Medivators, Inc.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): …
CSL Behring GmbH
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/2…
Medivators, Inc.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Boston Scientific
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Acutus Medical Inc
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laborato…
Alcon Research LLC
Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
Boston Scientific
Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Beckman Coulter Inc.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Degania Medical Devices Pvt. Ltd.
Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
Boston Scientific
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
Acutus Medical 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.