Browse Device Recalls

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
Feb 27, 2020 Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care o... During an FDA audit, it was discovered that the product was not properly registered with FDA. Class II Gentell, Inc
Feb 27, 2020 Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a... During an FDA audit, it was discovered that the product was not properly registered with FDA. Class II Gentell, Inc
Feb 27, 2020 Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care ... During an FDA audit, it was discovered that the product was not properly registered with FDA. Class II Gentell, Inc
Feb 18, 2020 PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versi... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2020 ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console S... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2020 ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #585... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 18, 2020 MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, ME... Potential safety issue with the dose monitoring system safety interlocks which could result in a ... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2020 Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137... A software issue could potentially cause the stand and table movements to be blocked. Class II Siemens Medical Solutions USA, Inc
Feb 14, 2020 Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Ar... A software issue could potentially cause the stand and table movements to be blocked. Class II Siemens Medical Solutions USA, Inc
Feb 14, 2020 Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848... A software issue could potentially cause the stand and table movements to be blocked. Class II Siemens Medical Solutions USA, Inc
Feb 10, 2020 Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray ... The Ysio system may process incorrect internal values for the position of its ceiling tube stand.... Class II Siemens Medical Solutions USA, Inc
Jan 24, 2020 ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 ... Potential exists for one or more axes of the robotic stand to become blocked by their safety brak... Class II Siemens Medical Solutions USA, Inc
Jan 21, 2020 COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes,... Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... Class II Aesculap Implant Systems LLC
Jan 21, 2020 AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, ... Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... Class II Aesculap Implant Systems LLC
Jan 21, 2020 COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, m... Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... Class II Aesculap Implant Systems LLC
Jan 21, 2020 COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, m... Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... Class II Aesculap Implant Systems LLC
Jan 21, 2020 Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, m... Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... Class II Aesculap Implant Systems LLC
Jan 16, 2020 COHERENCE Oncologist, Model Nos. 07333680 & 07351898 A potential safety issue arises when an offset calculation is followed by a filter operation; cor... Class II Siemens Medical Solutions USA, Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-0552... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International 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.