Browse Device Recalls

2,939 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,939 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 2,939 FDA device recalls in PA.

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DateProductReasonClassFirm
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
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code UR-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 BE-05400B-ETTEL 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-05500-TM 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-02220-SRH 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 ALZANO-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 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-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 UR-05501-EXP 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 MP-17019-TIP 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 DE-05400D-BO There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 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 AA-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 Epidural Catheterization Set for Pediatric Lumbar Placement, Pro... 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-DCS 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 JC-05400-LB 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 IT-05400-DC 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-05400-CA1 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, Open Tip, Single- Port Cathe... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 8, 2020 Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a... Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a d... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a dev... A software bug may lead to one image to be assigned to two different patients, which could potent... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a dev... Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a... A software bug may lead to one image to be assigned to two different patients, which could potent... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a... Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in coll... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is ... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic ... A software bug may lead to one image to be assigned to two different patients, which could potent... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Mod... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Jan 8, 2020 SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is ... Two software issues (1) Using the override function in case of blocked system movements affecting... Class II Siemens Medical Solutions USA, Inc
Dec 20, 2019 Arrow EPIDURAL NEEDLE COMPONENT AN-05505 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow EPIDURAL CATHETERIZATION KIT JH-05500 Product lidstock contains the incorrect expiration date for the product 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.