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 14 of 810
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.
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11…
Physio-Control, Inc.
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product De…
Medartis AG
GEM Premier 5000 PAK; Part No. 00055407508.
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445008.
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407510.
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360008.
Instrumentation Laboratory
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.
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.