Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 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 63 of 810
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Fem…
Onkos Surgical, Inc.
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M…
Onkos Surgical, Inc.
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Onkos Surgical, Inc.
iWALK Magnetic Wireless Power Banks Recalled Due to Fire and Burn Hazards; Manufactured by U2O Global
U2O Global Co. Ltd., of China
Organic traditions brand JUMBO PUMPKIN SEEDS; 227 g; 8 oz; Packaged and Distributed by: Advantage Health Matters Inc.; UPC: 6 27733 00175 5
Advantage Health Matters Inc.
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
C.R. Bard Inc
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professi…
Echopixel, Inc.
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Philips North America Llc
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Incorporated
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Philips North America Llc
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Centerline Biomedical Inc
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Philips North America Llc
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Cook Incorporated
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Advanced Bionics, LLC
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
C.R. Bard Inc
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew, Inc.
PhenoMATRIX
Copan WASP
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Philips North America Llc
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Philips North America Llc
Product Name: Ingenia 1.5T S; Model Number: 781347;
Philips North America Llc
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Philips North America Llc
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Philips North America Llc
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Philips North America Llc
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Philips North America Llc
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Baxter Healthcare Corporation
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Philips North America Llc
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ethicon Endo-Surgery Inc
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
C.R. Bard Inc
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Philips North America Llc
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
Philips North America Llc
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 38…
Becton Dickinson Infusion Therapy Systems, Inc.
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Philips North America Llc
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque R…
C.R. Bard Inc
Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
C.R. Bard Inc
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Philips North America Llc
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Philips North America Llc
Product Name: Upgrade to MR 7700; Model Number: 782130;
Philips North America Llc
True 3D Viewer, Model: EP-00003
Echopixel, Inc.
Intera 1.5T Master/Nova, Model Number: 781106;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Numed Inc
SmartPath to dStream for 3.0T, Model Number: 782145;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
MEDLINE INDUSTRIES, LP - Northfield
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 …
Beckman Coulter Inc.
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
SmartPath to dStream for 1.5T, Model Number: 782146;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
AVID Medical, Inc.
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended …
Abbott Molecular, Inc.
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN M…
Cook Incorporated
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 Jun 3, 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 Jun 3, 2026.