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 225 of 819
Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7-1/2" (190MM), REF F-1301
Carefusion 2200 Inc
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
Carefusion 2200 Inc
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124
Carefusion 2200 Inc
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928
Full Vision Inc
CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF…
Carefusion 2200 Inc
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Philips North America Llc
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Philips North America Llc
FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926
Full Vision Inc
CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302
Carefusion 2200 Inc
Philips Upgrade to MR 7700 System, Model Number 782130
Philips North America Llc
CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
Carefusion 2200 Inc
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalo…
Bunnell, Inc.
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069
Carefusion 2200 Inc
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002
Carefusion 2200 Inc
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noet…
Insulet Corporation
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Olympus Corporation of the Americas
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bla…
Cardinal Health
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells di…
Qvella Corporation
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal …
Integrity Implants Inc.
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
Remel Inc
3M Recalls Scotch™ Thermal Laminators Due to Fire Hazard
Accelerate PhenoTest BC kit REF 10101018
Accelerate Diagnostics Inc
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Busse Hospital Disposables, Inc.
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating p…
Greer Laboratories, Inc.
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Mobius Imaging, LLC
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c a…
Primus Corporation dba Trinity Biotech
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 m…
Intuitive Surgical, Inc.
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Cytocell Ltd.
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 …
GS Biomark LLC
Accelerate PhenoTest BC kit REF 10102018
Accelerate Diagnostics Inc
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering…
Cytocell Ltd.
Alcon Custom Pak Surgical Procedure Pack
Alcon Research, LLC
Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Busse Hospital Disposables, Inc.
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Primus Corporation dba Trinity Biotech
GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit fo…
Greer Laboratories, Inc.
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Owens & Minor Distribution, Inc.
CMV IgM EIA, in vitro diagnostic.
Bio-Rad Laboratories, Inc.
Polaris Recalls RZR Recreational Off-Road Vehicles Due to Fire Hazard (Recall Alert)
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
ROi CPS LLC
3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
3M Healthcare Business
regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
ROi CPS LLC
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Beckman Coulter, Inc.
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
ROi CPS LLC
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
3M Healthcare Business
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
ROi CPS LLC
InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Allison Medical, Inc.
regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
ROi CPS LLC
3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
3M Healthcare Business
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
ROi CPS LLC
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in…
Smiths Medical ASD 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.