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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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DateProductReasonClassFirm
Dec 31, 2018 cone-beam CT system ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 Class II KaVo Dental Technologies LLC
Dec 28, 2018 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Produc... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 28, 2018 12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No.... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 28, 2018 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Prod... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 28, 2018 12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No... The firm had a report of doctors being unable to pull the obstetric forceps apart. Class II Fetzer Medical GmbH & Co. KG
Dec 28, 2018 GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model B... Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when u... Class II GE Healthcare, LLC
Dec 27, 2018 Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Pr... Curity All Purpose Sponges were not sterilized and distributed Class II Cardinal Health 200, LLC
Dec 26, 2018 Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... Class I WEST PHARMA. SERVICES IL, LTD
Dec 26, 2018 ATLAS Loading Car The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when t... Class II Steris Corporation
Dec 26, 2018 Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... Class I WEST PHARMA. SERVICES IL, LTD
Dec 26, 2018 Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only Adverse events have been reported with the use of oxytocin in conjunction with the product in pre... Class I WEST PHARMA. SERVICES IL, LTD
Dec 26, 2018 Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G... On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica... Class III Luminex Corporation
Dec 26, 2018 Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, M... The sterile barrier may contain packaging seal defects. Class II Boston Scientific Corporation
Dec 26, 2018 Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Ma... The sterile barrier may contain packaging seal defects. Class II Boston Scientific Corporation
Dec 26, 2018 Eclipse(TM) Treatment Planning System with Proton Convolution Superposition a... There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Super... Class II Varian Medical Systems, Inc.
Dec 21, 2018 Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonan... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger Medical, Inc.
Dec 21, 2018 Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imagi... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imagi... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the siz... Class II Zimmer Biomet, Inc.
Dec 21, 2018 Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging ... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonanc... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imag... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Ima... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Res... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Im... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Reson... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resona... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 DigitalDiagnost C50, Stationary X-ray System During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing... Class II Philips Healthcare
Dec 21, 2018 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Produc... These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If ... Class I Edwards Lifesciences, LLC
Dec 21, 2018 Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance I... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging Sy... There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... Class II Philips Medical Systems Nederlands
Dec 21, 2018 ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesi... Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... Class I Draeger 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.