Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 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 150 of 808
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Philips North America
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take expos…
SEDECAL SA
Intera 1.5T, Model No. 781195
Philips North America
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
C.R. Bard Inc
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Diasorin Inc.
Achieva 1.5T, Model No. 781178, 781196, 781296
Philips North America
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Medtronic Inc.
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
C.R. Bard Inc
Bard¿ Suction Connector with ENFit, REF EN0066000
C.R. Bard Inc
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
B-K Medical A/S
REV 2 Flowcell Capsule Spare, Part Number: C04154
Beckman Coulter, Inc.
Achieva 1.5T Conversion, Model No. 781283
Philips North America
Ingenia Ambition X, Model No. 782109
Philips North America
Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
C.R. Bard Inc
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
C.R. Bard Inc
Snapshot NIR, REF: KD204
KENT IMAGING, INC.
Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
C.R. Bard Inc
Accure Laser System, Model: PFMS00004
Accure Acne, Inc
Model A710 Intellis Clinician Programmer Application, version 2.0.97
Medtronic Neuromodulation
Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
C.R. Bard Inc
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Cardinal Health 200, LLC
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and ban…
Steris Corporation
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Maquet Cardiovascular, LLC
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR…
Getinge Usa Sales Inc
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Olympus Corporation of the Americas
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Olympus Corporation of the Americas
Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD56901…
Getinge Usa Sales Inc
Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPW…
Getinge Usa Sales Inc
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Smiths Medical Asd Inc
Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - A…
Getinge Usa Sales Inc
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Smiths Medical Asd Inc
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Percussionaire Corporation
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A,…
Getinge Usa Sales Inc
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code:…
Waldemar Link GmbH & Co. KG (Mfg Site)
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an as…
Sarnova HC, Llc
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Smiths Medical Asd Inc
Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
Cardinal Health 200, LLC
Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
Cardinal Health 200, LLC
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Cook Medical Llc
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Greiner Bio-One North America, Inc.
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Philips North America
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
Philips North America
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Smiths Medical Asd Inc
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Randox Laboratories Ltd.
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left …
Oakworks Inc
Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMER…
Getinge Usa Sales Inc
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL…
Getinge Usa Sales Inc
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Getinge Usa Sales Inc
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Maquet Cardiovascular, 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 Jul 2, 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 2, 2026.