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 123 of 808
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Howmedica Osteonics Corp.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
Beaver Visitec International, Inc.
Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing F…
C.R. Bard Inc
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-40…
NxStage Medical Inc
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable ma…
Ethicon, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
Beaver Visitec International, Inc.
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foo…
Outset Medical, Inc.
Ventilator HAMILTON-C6, PN: 160021
Hamilton Medical AG
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e…
Exactech, Inc.
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38M…
Exactech, Inc.
Head Rush Technologies Recalls TRUBLUE iQ Auto Belay Devices Due to Fall Hazard
Head Rush Technologies, of Louisville, Colorado
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Wondfo USA Co Ltd
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Di…
Wondfo USA Co Ltd
OMTech Desktop Laser Engraver
Rygel Advanced Machines d/b/a Omtech Laser
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep…
Wondfo USA Co Ltd
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
B Braun Medical Inc
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Covidien, LLC
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO…
Avanos Medical, Inc.
Aeos Robotic Digital Microscope, Product Code: PV010
Aesculap Inc
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog…
Mckesson Medical-Surgical Inc. Corporate Office
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (ME…
Canon Medical System, USA, INC.
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO…
Avanos Medical, Inc.
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundarie…
Blue Belt Technologies, Inc
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step …
Wondfo USA Co Ltd
Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
B Braun Medical Inc
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Young Dental Manufacturing I, LLC
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Nu…
Fresenius Medical Care Holdings, Inc.
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number …
Wondfo USA Co Ltd
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - g…
Ortho-Clinical Diagnostics, Inc.
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission comput…
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible device…
Integra LifeSciences Corp.
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensi…
Integra LifeSciences Corp.
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left …
Thoratec Corp.
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO;…
Avanos Medical, Inc.
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
B Braun Medical Inc
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatib…
Integra LifeSciences Corp.
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
B Braun Medical Inc
Daikin Comfort Technologies Manufacturing Recalls Amana, Daikin, Goodman-Branded Air Conditioning and Heat Pump Packaged Units Due to Fire Hazard
Daikin Comfort Technologies Manufacturing L.P. (f/k/a Goodman Manufacturing Company L.P.), of Houston, Texas
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diam…
Stryker Neurovascular
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
MEDLINE INDUSTRIES, LP - Northfield
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
Philips North America Llc
ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Atrium Medical Corporation
ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Atrium Medical Corporation
FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
Newport Corp
ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record …
Nihon Kohden America Inc
ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
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.