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.

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Date	Product	Reason	Class	Firm
Jul 24, 2018	ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage...	A potential bias was identified with certain kits compared to the internal standards.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 24, 2018	Stryker Mako Vizadisc Hip Procedure Tracking Kit	Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit...	Class II	Mako Surgical Corporation
Jul 24, 2018	GE 9100c NXT anesthesia systems	On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the aux...	Class II	GE Medical Systems China Co., Ltd.
Jul 24, 2018	ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: ...	A potential bias was identified with certain kits compared to the internal standards.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 24, 2018	GE Carestation 30 anesthesia systems	On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the aux...	Class II	GE Medical Systems China Co., Ltd.
Jul 24, 2018	Stryker Mako Vizadisc Knee Procedure Tracking Kit	Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit...	Class II	Mako Surgical Corporation
Jul 24, 2018	BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PL...	BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual ste...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Jul 24, 2018	Diagnostica Stago STA N¿oplastine¿ CI Plus, 10 ml vial. In-Vitro Diagnostic...	QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)	Class II	Diagnostica Stago, Inc.
Jul 24, 2018	YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, ...	Screws had a manufacturing error that could prevent the screw from mating with the screw inserter...	Class II	K2M, Inc
Jul 24, 2018	Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: ...	A potential bias was identified with certain kits compared to the internal standards.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 24, 2018	ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vit...	A potential bias was identified with certain kits compared to the internal standards.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 24, 2018	Diagnostica Stago STA N¿oplastine¿ CI, 10 ml vial. In-Vitro Diagnostic for d...	QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)	Class II	Diagnostica Stago, Inc.
Jul 24, 2018	GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems	On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the aux...	Class II	GE Medical Systems China Co., Ltd.
Jul 24, 2018	Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vit...	A potential bias was identified with certain kits compared to the internal standards.	Class II	Siemens Healthcare Diagnostics, Inc
Jul 23, 2018	Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 0234...	The products failed the filed specification of 1.0kPa for Burst Pressure.	Class II	Reckitt Benckiser LLC
Jul 23, 2018	Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On ...	There is a software issue that can potentially impact sample identification and traceability unde...	Class II	Tecan US, Inc.
Jul 23, 2018	Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve...	Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, ...	Class II	Johnson & Johnson Vision Care, Inc.
Jul 23, 2018	EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage...	An issue with the power branching printed circuit board (PCB) on the instrument that has the pote...	Class II	Qiagen Sciences LLC
Jul 20, 2018	CE17TB19C CONT EPIDURAL TRAY, Material Number 332242 Connection device us...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection de...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	GOVCE18TK ACCU-BLOC PERIFIX KIT, Material Number 332600 Connection device...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TKFPS PERIFIX FX CONT. EPID TRAY-LF, Material Number 332087 Connectio...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device u...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connecti...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 Connection device u...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connecti...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used ...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection dev...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection devi...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 Connection device u...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection devic...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 Connectio...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CNB400TK CONTIPLEX CONT NERVE BLOCK, Material Number 331706 Connection de...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection d...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TKFS EPIDURAL TRAY, Material Number 332098 Connection device used by ...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CNBFX350C CONTIPLEX CONT NERVE BLOCK, Material Number 331672 Connection d...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE18HK ACCU-BLOC PERIFIX KIT, Material Number 332230 Connection device us...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 Connection d...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE18TIN CONT EPIDURAL SET LF, Material Number 332201 Connection device us...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CNB200S CONTIPLEX INSULATED TUOHY NDL, Material Number 331697 Connection ...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CEP20TO CONT EPID PEDIATRIC SET, Material Number 332293 Connection device...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE17TO CONT EPIDURAL SET LF, Material Number 332204 Connection device use...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	EC19C 19G X 100CM CATHETER CLOSED, Material Number 333511 Connection devi...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CLAMP STYLE CATHETER CONNECTOR 20GA- LF, Material Number 332283 Connectio...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CNB400TKU NON-STIM CATH FULL KIT, Material Number 332128 Connection devic...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CE18TKST CONT EPID W/SOFT TIP, Material Number 332081 Connection device u...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.
Jul 20, 2018	CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 Connection...	The catheter connectors may not stay closed during in and in some cases, leakage or disconnection...	Class II	B. Braun Medical, Inc.

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.