Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- 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 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 recalls
Recalls in Medical Devices
Newest first · Page 13 of 810
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutt…
Olympus Corporation of the Americas
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 3215…
I.T.S. GmbH
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article N…
I.T.S. GmbH
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CEN…
Merit Medical Systems, Inc.
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Erbe USA Inc
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Num…
I.T.S. GmbH
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Co…
I.T.S. GmbH
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Olympus Corporation of the Americas
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Merit Medical Systems, Inc.
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The…
Olympus Corporation of the Americas
Philips S4-1 Ultrasound Transducer
Philips Ultrasound, Inc
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
GE Medical Systems, LLC
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics, Inc.
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Olympus Corporation of the Americas
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
CareFusion 303, Inc.
Philips X3-1 Ultrasound Transducer
Philips Ultrasound, Inc
Philips OMNI II TEE Ultrasound Transducer
Philips Ultrasound, Inc
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly…
Olympus Corporation of the Americas
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Medtronic MiniMed, Inc.
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Waldemar Link GmbH & Co. KG (Mfg Site)
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Merit Medical Systems, Inc.
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to d…
Tandem Diabetes Care, Inc.
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Olympus Corporation of the Americas
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Fe…
I.T.S. GmbH
Philips L17-5 Ultrasound Transducer
Philips Ultrasound, Inc
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/E…
Merit Medical Systems, Inc.
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Navajo Manufacturing Company
Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Olympus Corporation of the Americas
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Straumann USA LLC
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Articl…
I.T.S. GmbH
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Mod…
AMO Puerto Rico Manufacturing, Inc.
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product D…
Olympus Corporation of the Americas
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Nu…
I.T.S. GmbH
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H78…
Merit Medical Systems, Inc.
Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, …
I.T.S. GmbH
Philips Mini Multi TEE Ultrasound Transducer
Philips Ultrasound, Inc
Philips OMNI III TEE Ultrasound Transducer
Philips Ultrasound, Inc
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.…
I.T.S. GmbH
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Waldemar Link GmbH & Co. KG (Mfg Site)
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
Straumann USA LLC
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
I.T.S. GmbH
Philips 3D6-2 Ultrasound Transducer
Philips Ultrasound, Inc
Philips X7-2 Ultrasound Transducer
Philips Ultrasound, Inc
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: …
I.T.S. GmbH
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Pro…
Olympus Corporation of the Americas
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cu…
Olympus Corporation of the Americas
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (…
Koven Technology, Inc.
Philips C9-4 Ultrasound Transducer
Philips Ultrasound, Inc
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Erbe USA Inc
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032…
I.T.S. GmbH
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 Jun 3, 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 Jun 3, 2026.