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 · 2026-09-01
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 706 of 822
Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. …
Amerx Health Care Corp.
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intende…
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from…
EMG Technology Co., Ltd.
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstru…
Philips Medical Systems (Cleveland) Inc
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL De…
Bio-Detek, Inc.
Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered …
Genesis BPS, LLC.
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of f…
Genesis BPS, LLC.
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear acce…
Varian Medical Systems, Inc.
Siemens Recalls Audible Fire Alarm Base Due to Risk of Injury
Beijing Siemens Cerberus Electronics Ltd., of China
CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange uni…
GE Healthcare, LLC
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retr…
Baxter Healthcare Corp
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Life Force of Tampa, LLC
AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, me…
Ab Sciex
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft …
Biomet 3i, LLC
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, …
PIONEER SURGICAL TECHNOLOGY, INC.
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radi…
Siemens Medical Solutions USA, Inc
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Steri…
Ethicon Endo-Surgery Inc
DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinf…
Catheter Connections, Inc.
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing …
Illumina Inc
***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adap…
Baxter Healthcare Corp
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
CooperSurgical, Inc.
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to pro…
Medtronic Cardiovascular Surgery-the Heart Valve Division
CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc s…
Stryker Spine
Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size…
Integra York PA, Inc
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, re…
Radiometer America Inc
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Stap…
Becton Dickinson & Co.
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into th…
Stryker Spine
***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***wit…
Baxter Healthcare Corp
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Wright Medical Technology, Inc.
Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced…
Primus Medical LLC
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retriev…
Concentric Medical Inc
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BUL…
Customed, Inc
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWEL…
Customed, Inc
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction S…
OrthoPediatrics Corp
LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFOR…
Customed, Inc
ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REI…
Customed, Inc
PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90" LIF (2) D…
Customed, Inc
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEA…
Customed, Inc
FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY L…
Customed, Inc
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GO…
Customed, Inc
UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAUMGARTNER 5" …
Customed, Inc
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce cathet…
Galt Medical Corporation
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.