Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,013 FDA device recalls in 2018.

Clear

Date	Product	Reason	Class	Firm
Aug 2, 2018	OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 ...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 ...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazon...	The product is labeled with an incorrect expiration date.	Class III	Acumedia Manufacturers, Inc.
Aug 2, 2018	ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 ...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media...	Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and labe...	Class III	Acumedia Manufacturers, Inc.
Aug 2, 2018	CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody,...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 ...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immun...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 7...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-09...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, M...	The implant only has one bolt in the sterile package but it should have had two.	Class II	Zimmer Biomet, Inc.
Aug 2, 2018	CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antib...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Mo...	The implant only has one bolt in the sterile package but it should have had two.	Class II	Zimmer Biomet, Inc.
Aug 2, 2018	NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 76...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistoche...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohi...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, M...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-0...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers	Class I	Ventana Medical Systems Inc
Aug 2, 2018	ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 7...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohis...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, ...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 2, 2018	INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 80...	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false neg...	Class I	Ventana Medical Systems Inc
Aug 1, 2018	Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, ...	Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.	Class II	Allied Vision Group Inc
Aug 1, 2018	Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ...	A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a ...	Class II	ICU Medical Inc
Aug 1, 2018	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, ...	Potential for product sterility breach due to a compromised or pinched seal defect	Class II	COVIDIEN LLC
Aug 1, 2018	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), ...	Potential for product sterility breach due to a compromised or pinched seal defect	Class II	COVIDIEN LLC
Aug 1, 2018	sterEOS workstation	3D projections may be incorrect when the pair of images used is a secondary capture generated fr...	Class II	EOS Imaging
Aug 1, 2018	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441...	Potential for product sterility breach due to a compromised or pinched seal defect	Class II	COVIDIEN LLC
Aug 1, 2018	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3....	Potential for product sterility breach due to a compromised or pinched seal defect	Class II	COVIDIEN LLC
Aug 1, 2018	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - ...	There is a potential for increased imprecision, out of range quality controls and prolonged sampl...	Class II	Instrumentation Laboratory Co.
Aug 1, 2018	Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 ...	Potential for product sterility breach due to a compromised or pinched seal defect	Class II	COVIDIEN LLC
Aug 1, 2018	AIRO Mobile CT System Model # MobiCT-32	The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with softwar...	Class II	Mobius Imaging, LLC
Aug 1, 2018	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), ...	Potential for product sterility breach due to a compromised or pinched seal defect	Class II	COVIDIEN LLC
Jul 31, 2018	CAPNOSTREAM 20 (US) N, Part Number CS08651	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (US) M W/PRINTER, Part Number CS08659	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (INTL) M W/PRINTER, CS08660	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AF...	Endologix is notifying physicians of patient tailored surveillance recommendations as well as gen...	Class I	Endologix
Jul 31, 2018	Capnostream20 M W/PRINTER CYVITAL, CS08796	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (US) N, Part Number CS08651-01	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 N W/PRINTER CYVITAL, CS08798	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	Capnostream20 (US) N REFURBISHED, Part Number CS78651	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.
Jul 31, 2018	CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02	The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the fac...	Class II	Oridion Medical 1987 Ltd.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.