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 247 of 819
MBB Tray Catalog Number: 9882
Busse Hospital Disposables, Inc.
Epidural Tray Catalog 1577
Busse Hospital Disposables, Inc.
SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
Busse Hospital Disposables, Inc.
Single Shot Epidural Tray Catalog 1165
Busse Hospital Disposables, Inc.
Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
Busse Hospital Disposables, Inc.
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm;…
ProgenaCare
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
ConvaTec, Inc
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part o…
Medtronic Neuromodulation
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Umano Medical, Inc.
KWIK-STIK" plus: Clostridium perfringens
Microbiologics Inc
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed i…
Medtronic Perfusion Systems
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Fil…
TELEFLEX MEDICAL INC
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Medtronic Neuromodulation
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Invacare Corporation
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Devicor Medical Products Inc
Surgical Suture Kit
Stradis Healthcare
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Medtronic Neuromodulation
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Umano Medical, Inc.
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Smith & Nephew Orthopaedics GmbH
Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual…
International Science & Technology, LP, DBA Diamatrix Ltd.
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Steris Corporation
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Olympus Corporation of the Americas
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include t…
Accriva Diagnostics, Inc.
Sara Plus Active Floor Lift
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo …
TELEFLEX MEDICAL INC
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
MEDLINE INDUSTRIES, LP - Northfield
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
Steris Corporation
MicroScan WalkAway-40 plus Instrument REF B1018-283
Beckman Coulter Inc.
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Caire, Inc.
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Beckman Coulter Inc.
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Luminex Corporation
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, …
Radiometer Medical ApS
Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Table…
Total Resources Intl
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Baxter Healthcare Corporation
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Beckman Coulter Inc.
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Ortho-Clinical Diagnostics, Inc
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Getinge Usa Sales Inc
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Heartware, Inc.
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Bio-Rad Laboratories, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Heartware, Inc.
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction o…
Clinician's Choice Dental Products Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Heartware, Inc.
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
Boston Scientific Corporation
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 8…
Atrium Medical Corporation
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 8…
Atrium Medical Corporation
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Ortho-Clinical Diagnostics, Inc
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use w…
Boston Scientific Corporation
CK MB Calibrator, Catalogue Number CK2393
Randox Laboratories Ltd.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergenc…
Heartware, 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.