Product category · Updated Aug 19, 2026

Medical Devices recalls

Name: Medical Devices Recalls
Creator: PlainRecalls
License: https://creativecommons.org/publicdomain/zero/1.0/

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls: 41,070
Top agency: FDA Devices
Years covered: 2000–2026

Compiled from official public sources by the publisher. · Updated September 2026

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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 · 2026-09-27

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.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-27.

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

High severity

3,653
Moderate

36,361
Lower severity

1,056

FDA Devices

39,794
FDA Drug

934
CPSC

307
FDA Food

35

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 136 of 822

Where Medical Devices sits among all 12 categories

Do more recalls mean more Class I danger?

Recalls in Medical Devices

COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator

Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator

MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator

Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator

SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator

AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431

MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 475525

Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001

AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator

RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator

AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718

Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415

EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator

AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399

ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900

PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator

Inspire Model 3028, IV Implantable Pulse Generator

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator

Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230

SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator

Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767

EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

Focusee Recalls Tideway Hair Dryers Due to Electrocution or Shock Hazard

Baseus Magnetic Wireless Charging Power Banks Recalled Due to Fire Hazard; Imported by Shenzhen Baseus Technology

Daikin Comfort Technologies Manufacturing Recalls Daikin FIT, Amana Brand S-series, and Goodman SD Heat Pumps Due to Risk of Excessive Heat Exposure

MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H

OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910

VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H

HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900

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Dietary Supplements

Data sources