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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Jul 15, 2026
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jul 15, 2026
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp. (NeuroSciences)
FDA (openFDA device enforcement)
Reported Jul 15, 2026
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Klowen Braces
FDA (openFDA device enforcement)
Reported Jul 15, 2026
Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2026
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Jul 15, 2026
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jul 15, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jul 15, 2026
TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Think Surgical, Inc.
FDA (openFDA device enforcement)
Reported Jul 15, 2026
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wallac Oy
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accuray Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Access Systems, Inc.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Jul 8, 2026
CRE Pro Wireguided 6-8mm 240cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carl Zeiss Meditec AG
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Depuy (ireland)
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hamilton Medical AG
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Insulet Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Laborie Medical Technologies Corp.
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Radius VSM ECG pre-connected Set, REF: 4842, 4695
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Masimo Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medacta USA Inc.
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medela Inc.
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
23 more products in this recall
FDA (openFDA device enforcement)
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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.