Browse Device Recalls

478 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 478 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 478 FDA device recalls.

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DateProductReasonClassFirm
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
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
Dec 20, 2019 Arrow EPIDURAL NEEDLE KIT SL-05500 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow SPINAL ANESTHESIA SET ASA-25090-S Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow EPIDURAL CATHETERIZATION KIT AM-05500 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow Maximal Barrier Drape ASK-00002-1A Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ S... Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow EPIDURAL CATHETERIZATION KIT CK-02220 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow EPIDURAL CATHETERIZATION KIT YC-02220 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow Central Venous Catheterization Kit ASK-04200-UPM Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 PICC Set- PR-35052-HPHNM Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 20, 2019 Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1 Product lidstock contains the incorrect expiration date for the product Class II Arrow International Inc
Dec 12, 2019 Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane ove... The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instea... Class II Arrow International Inc
Dec 6, 2019 Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Ca... Class II Arrow International Inc
Nov 15, 2019 Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 Potential leak in the balloon extension line. If a leak was present and went undetected during pr... Class II Arrow International Inc
Nov 15, 2019 Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J Potential leak in the balloon extension line. If a leak was present and went undetected during pr... Class II Arrow International Inc
Aug 6, 2019 Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product ... Products may contain the incorrect banner card within the kit Class II Arrow International Inc
Aug 6, 2019 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Cat... Products may contain the incorrect banner card within the kit Class II Arrow International Inc
Jul 18, 2019 Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circ... Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm ... Class II Arrow International Inc
May 17, 2019 Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARR... Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (... Class II Arrow International Inc
Apr 23, 2019 Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A Lidstock states 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.