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 · 2026-09-20
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 8 of 822
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 1194108D1 PowerPICC SOL
Bard Access Systems, Inc.
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Windstone Medical Packaging, Inc.
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Windstone Medical Packaging, Inc.
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
Zimmer Surgical Inc
CRE Pro Wireguided 18-20mm 240cm
Boston Scientific Corporation
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Medacta Usa Inc
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
BD SWITZERLAND SARL
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Hamilton Medical AG
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
Insulet Corporation
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086984 5615120 Power-Trialysis Short-Term Curved Extension Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741075087 5615200 Power-Trialysis Short-Term Curve
Bard Access Systems, Inc.
ARTIS icono ceiling. Model Number: 11328100.
Siemens Medical Solutions USA, Inc
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Baxter Healthcare Corporation
Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC255
Medline Industries, LP
Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
Medline Industries, LP
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Baxter Healthcare Corporation
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System
Dexcom, Inc.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Zimmer, Inc.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Ventec Life Systems, Inc.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L
Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62
Medline Industries, LP
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Abiomed, Inc.
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE
Medline Industries, LP
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Philips North America Llc
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Medtronic Perfusion Systems
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Zimmer, Inc.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Abiomed, Inc.
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
INZONE DETACHMENT SYSTEM, REF: M00345100950
Stryker Neurovascular
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Intuitive Surgical, Inc.
Octopus 4 Tissue Stabilizer, Model 29400
Medtronic Perfusion Systems
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROL
Medline Industries, LP
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Boston Scientific Corporation
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
IPG Medical Corporation
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Zimmer, Inc.
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Abiomed, Inc.
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ
Medline Industries, LP
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP
Medline Industries, LP
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
PFM MEDICAL INC.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & accessories (simple, powered)
SURGIFY MEDICAL OY
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ4412
Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F
Medline Industries, LP
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.