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 Oct 5, 2022
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Malvern Panalytical Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Mckesson Medical-Surgical Inc. Corporate Office
22 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Micro-X Ltd.
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur Americas
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
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 Oct 5, 2022
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Moderate riskThis product could cause temporary or reversible health problems — stop using it.SunMed Holdings, LLC
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Surgical Innovations Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tandem Diabetes Care Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 5, 2022
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Unomedical A/S
FDA (openFDA device enforcement)
Reported Sep 28, 2022
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Associates
FDA (openFDA device enforcement)
Reported Sep 28, 2022
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion
8 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2022
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
FDA (openFDA device enforcement)
Reported Sep 28, 2022
Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Diversatek Healthcare
FDA (openFDA device enforcement)
Reported Sep 28, 2022
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ethicon, Inc.
FDA (openFDA device enforcement)
Reported Sep 28, 2022
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2022
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gelita Medical GmbH
FDA (openFDA device enforcement)
Reported Sep 28, 2022
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 28, 2022
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragon 28, Inc.
FDA (openFDA device enforcement)
Reported Sep 28, 2022
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcor Scientific, Inc.
FDA (openFDA device enforcement)
Reported Sep 21, 2022
BIOPHEN UFH Control Plasma
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Aniara Diagnostica LLC
FDA (openFDA device enforcement)
Reported Sep 21, 2022
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Baxter Healthcare Corporation
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.