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 14 of 808
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
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibili…
Beckman Coulter, Inc.
Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: …
Olympus Corporation of the Americas
Philips L12-5 Ultrasound Transducer
Philips Ultrasound, Inc
Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2…
I.T.S. GmbH
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"
Medline Industries, LP
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics, Inc.
Battery Charging Station; Model: 0998-00-0802;
Datascope Corp.
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Howmedica Osteonics Corp.
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Espri…
Elekta, Inc.
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from va…
GE Medical Systems, LLC
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is …
Diagnostica Stago, Inc.
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
ConvaTec, Inc
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
ConvaTec, Inc
Artegraft Vascular Graft; REF#: AG740;
LeMaitre Vascular, Inc.
Cub Pediatric Crib, Model FL19H
Stryker Medical Division of Stryker Corporation
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Hologic, Inc.
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data fro…
GE Medical Systems, LLC
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nu…
Abbott Diagnostics Scarborough, Inc.
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version …
Baxter Healthcare Corporation
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from var…
GE Medical Systems, LLC
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
ConvaTec, Inc
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Waldemar Link GmbH & Co. KG (Mfg Site)
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Penner Patient Care, Inc.
GEM Premier 5000 PAK, Part No. 00055360004.
Instrumentation Laboratory
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Beckman Coulter Mishima K.K.
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Met…
Trividia Health, Inc.
Artelon FlexBand Dynamic Matrix Ref: 31057
International Life Sciences
GEM Premier 5000; Part No. 00055415005.
Instrumentation Laboratory
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Waldemar Link GmbH & Co. KG (Mfg Site)
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX…
Trividia Health, Inc.
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Waldemar Link GmbH & Co. KG (Mfg Site)
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobi…
Raz Design Inc
GEM Premier 5000; Model No. 00055430010.
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430008.
Instrumentation Laboratory
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Waldemar Link GmbH & Co. KG (Mfg Site)
GEM Premier 5000; Part No. 00055415008.
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407511.
Instrumentation Laboratory
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Num…
Medline Industries, LP
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Exactech, Inc.
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 36…
Penner Patient Care, Inc.
GEM Premier 5000 PAK; Part No. 00055360011.
Instrumentation Laboratory
DxC 700 AU, REF: B86444, B86446
Beckman Coulter Mishima K.K.
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.