Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Aug 26, 2026Updated Sep 7, 2026
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics Products Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Lago X
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectral Instruments Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tobii Dynavox LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bioporto Diagnostics A/S
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Sep 7, 2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Erbe USA Inc.
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Galt Medical Corporation
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microvention Inc.
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OBP Medical Corporation
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Sep 4, 2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remel Europe Ltd.
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Inc.
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Spectra Medical Devices, LLC
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Straumann USA LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Terumo Medical Corporation
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ventana Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.W L Gore & Associates, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Waldemar Link GmbH & Co. KG (Mfg Site)
FDA (openFDA device enforcement)
Free recall alerts
Get alerted about new Medical device recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.
Related categories
RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.