Product category · Updated Aug 19, 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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.
- 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.
- 41,070
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Where Medical Devices sits among all 12 categories
Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.
Medical Devices vs all categories by recall count
Where this category's archive sits among every tracked product class
41,070 1st of 12 the highest of 12 categories
Categories, banded by distinct recall-event inventory
Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-10-03
Do more recalls mean more Class I danger?
Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.
Read the chart, every category as text
Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.
| Category | Recalls | Vol %ile | Classified | Class I | Class I % | Rate %ile |
|---|---|---|---|---|---|---|
| Medical Devices | 41,070 | 100 | 40,763 | 3,653 | 9% | 14 |
| Food | 25,513 | 86 | 25,222 | 11,676 | 46.3% | 86 |
| Drugs & Medications | 14,473 | 71 | 14,417 | 1,508 | 10.5% | 29 |
| Children & Baby Products | 4,017 | 57 | 2,483 | 352 | 14.2% | 43 |
| Dietary Supplements | 2,018 | 43 | 1,993 | 466 | 23.4% | 71 |
| Meat & Poultry | 1,672 | 29 | 1,672 | 1,145 | 68.5% | 100 |
| Cosmetics & Personal Care | 1,388 | 14 | 1,289 | 203 | 15.7% | 57 |
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,653
High severity
3,653 recalls
- Moderate
Moderate
36,361 recalls
- Lower severity 1,056
Lower severity
1,056 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,794 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 242 of 822
CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260
Family Dollar Stores, Llc.
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well
Siemens Medical Solutions USA, Inc
DENTEMP ONE STEP .077OZ, SKU 902139
Family Dollar Stores, Llc.
OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
Family Dollar Stores, Llc.
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Stradis Medical, LLC dba Stradis Healthcare
GS SALINE SOLUTION 12FL OZ, SKU 902274
Family Dollar Stores, Llc.
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
Family Dollar Stores, Llc.
POLIDENT DENTURE CLEANSERS 84 CT, SKU 901634 POLIDENT DENTURE CLNS TAB 28CT, SKU 906131
Family Dollar Stores, Llc.
POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREAM .75OZ, SKU 900085
Family Dollar Stores, Llc.
VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504
Family Dollar Stores, Llc.
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 environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. Catalog Number: 515304
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 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
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 glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid
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, DDPA2D4
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, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
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, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems.
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 syringe. Catalog Number: NRSS1-23G25
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. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
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 retractable safety syringe. Catalog Number: NRSS1-25G25
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; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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 Aug 19, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.