Product category · Updated Jul 29, 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 (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 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 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 352 of 819
BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
Biomet, Inc.
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Biomet, Inc.
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
Biomet, Inc.
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8…
James Leckey Design Ltd
GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered i…
Baxter Healthcare Corporation
ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Siemens Medical Solutions USA, Inc
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Biomet, Inc.
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
Biomet, Inc.
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Siemens Medical Solutions USA, Inc
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Biomet, Inc.
Pass & Seymour Recalls Commercial-Grade Electrical Receptacles Due to Burn Hazard
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Cathe…
LeMaitre Vascular, Inc.
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Trilliant Surgical, LLC
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is ind…
Gentell, Inc
Philips V60 Ventilators with Power Management PCBA part number 1055906
Respironics California, LLC
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Maquet Cardiovascular Us Sales, Llc
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001;…
Trilliant Surgical, LLC
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Soft…
Butterfly Network, Inc.
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm…
Trilliant Surgical, LLC
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product …
Philips North America, LLC
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound…
Gentell, Inc
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, D…
Karl Storz Endoscopy
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 A…
Physio-Control, Inc.
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. Th…
Trilliant Surgical, LLC
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructe…
Smith & Nephew, Inc.
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indi…
Gentell, Inc
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: St…
Stryker Neurovascular
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, …
Bard Peripheral Vascular Inc
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder repla…
Biomet, Inc.
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The fi…
Trilliant Surgical, LLC
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 2…
Trilliant Surgical, LLC
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Merits Holdings Co. dba Merits Health Products, Inc.
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: St…
Stryker Neurovascular
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.…
Butterfly Network, Inc.
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is ind…
Gentell, Inc
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Haemonetics Corporation
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Stryker Communications
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement Sy…
Conformis, Inc.
Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitili…
Ra Medical Systems, Inc.
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The f…
Trilliant Surgical, LLC
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Mode…
Trilliant Surgical, LLC
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001.…
Trilliant Surgical, LLC
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian D…
Qiagen Sciences LLC
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
The Binding Site Group, Ltd.
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replaceme…
Conformis, Inc.
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The f…
Trilliant Surgical, LLC
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. Th…
Trilliant Surgical, LLC
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
DeRoyal Industries Inc
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
Medtronic MiniMed
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 29, 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 29, 2026.