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 1, 2026
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Accriva Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AMD Medicom Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
High riskUsing this product could cause serious injury, illness or death — stop using it now.Arrow International, LLC
34 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Jun 24, 2026
iLet Bionic Pancreas, REF: BB1001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beta Bionics, Inc.
FDA (openFDA device enforcement)
Reported Jun 24, 2026
ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ConMed Corporation
10 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex-Ohmeda Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inspire Medical Systems Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Medline EBSI Kit EBSI1534
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
63 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Mito Red Light, Super Mobile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mito Red Light Inc.
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Staar Surgical AG
FDA (openFDA device enforcement)
Reported Jun 24, 2026
HarmonyAIR A-Series Surgical Lighting System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thoratec LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Medical
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Avanos Medical, Inc.
19 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Halyard, Pain Pack. Kit Code: AMPK48-01.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AVID Medical, Inc.
3 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.