Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.
- 40,372 total recalls
- 39.7% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.
- 40,372
- 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 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 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 85 of 808
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using t…
Abbott Medical
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
MEDLINE INDUSTRIES, LP - Northfield
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation cathet…
Abbott Vascular Inc
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
Siemens Healthcare Diagnostics, Inc.
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
O&M HALYARD, INC.
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Abbott Vascular Inc
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Limacorporate S.p.A
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU D…
MEDLINE INDUSTRIES, LP - Northfield
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Moximed, Inc.
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119…
MEDLINE INDUSTRIES, LP - Northfield
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Braemar Manufacturing, LLC
RUMMELL, Medline Item No. ST006ST
MEDLINE INDUSTRIES, LP - Northfield
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/…
Waldemar Link GmbH & Co. KG (Mfg Site)
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the f…
Becton, Dickinson and Company, BD Bio Sciences
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
MEDLINE INDUSTRIES, LP - Northfield
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
O&M HALYARD, INC.
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Becton, Dickinson and Company, BD Bio Sciences
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
Siemens Healthcare Diagnostics, Inc.
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: Th…
Becton, Dickinson and Company, BD Bio Sciences
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
MEDLINE INDUSTRIES, LP - Northfield
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) N…
MEDLINE INDUSTRIES, LP - Northfield
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically suppl…
Straight Smile, LLC
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The…
Becton, Dickinson and Company, BD Bio Sciences
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as…
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professional…
Siemens Healthcare Diagnostics, Inc.
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Prod…
SEASPINE ORTHOPEDICS CORPORATION
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device…
Becton, Dickinson and Company, BD Bio Sciences
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Nova Biomedical Corporation
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocard…
Spacelabs Healthcare, Ltd.
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-po…
CooperSurgical, Inc.
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained s…
GE OEC Medical Systems, Inc
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMA…
MicroPort Orthopedics Inc.
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthe…
Draeger Medical, Inc.
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spo…
GE OEC Medical Systems, Inc
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-pow…
CooperSurgical, Inc.
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Philips North America Llc
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666…
Medtronic Neurosurgery
mint Lesion, Software Versions: 3.9.0 through 3.9.5.
Mint Medical GmbH
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are d…
Kirwan Surgical Products, LLC
Duravent Silicone Ventilation Tube. Model Number: 240075.
Olympus Corporation of the Americas
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopi…
GE OEC Medical Systems, Inc
mint Lesion, Software Versions: 3.10.0 and 3.10.1.
Mint Medical GmbH
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are de…
Kirwan Surgical Products, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo),…
Augustine Temperature Management, LLC
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipol…
Kirwan Surgical Products, LLC
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 Jul 2, 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 Jul 2, 2026.