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 239 of 819
CURAD FIRST AID KIT, SKU 999037
Family Dollar Stores, Llc.
SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801
Family Dollar Stores, Llc.
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Myolyn Inc.
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of en…
Becton Dickinson & Company
FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
Family Dollar Stores, Llc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Heartware, Inc.
ARIES SARS-CoV-2 Assay
Luminex Corporation
LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265
Family Dollar Stores, Llc.
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Trinity Sterile, Inc.
Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
Micro Therapeutics, Inc.
Veriquick Pregnancy Test 2CT, SKU 903756
Family Dollar Stores, Llc.
GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
Family Dollar Stores, Llc.
B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009
Family Dollar Stores, Llc.
NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
Stradis Medical, LLC dba Stradis Healthcare
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 …
ASO LLC
AT HOME MARIJUANA TEST STRIP, SKU 900752
Family Dollar Stores, Llc.
NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
Stradis Medical, LLC dba Stradis Healthcare
Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF
Trinity Sterile, Inc.
SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
Family Dollar Stores, Llc.
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Abbott Molecular, Inc.
NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417
Family Dollar Stores, Llc.
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and…
Alere San Diego, Inc.
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DD…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Medical Modeling, Inc.
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Xhibit Telemetry Receiver, Model: 96280
Spacelabs Healthcare, Inc.
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Corin Ltd
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Aesculap Implant Systems LLC
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Olympus Corporation of the Americas
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunl…
GE Healthcare, LLC
cobas e801 Immunoassay Analyzer
Roche Diagnostics Operations, Inc.
Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety s…
Guangdong Haiou Medical Apparatus Co., Ltd
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Haimen Shengbang Laboratory Equipment Co. Ltd.
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Haimen Shengbang Laboratory Equipment Co. Ltd.
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Haimen Shengbang Laboratory Equipment Co. Ltd.
HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle …
Guangdong Haiou Medical Apparatus Co., Ltd
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1;…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Merlin 2 PCS MER37000 programmer Model MER3400 software
St. Jude Medical, Cardiac Rhythm Management Division
Merlin PCS 3650 programmer Model 3330 software
St. Jude Medical, Cardiac Rhythm Management Division
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Aesculap Implant Systems LLC
NanoSight NS300
MALVERN PANALYTICAL LTD
CustMbite, Model Number CBT-SRS-UL
Dental Choice Holding Llc
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Aesculap Implant Systems LLC
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is insta…
Intuitive Surgical, Inc.
Craftmatic Model 1 Base for Dual Bed Configurations
Craftmatic Industries, Inc.
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Neotract Inc
Turbett Surgical Container, TS1500
Turbett Surgical, 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.