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Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 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 3,037 FDA device recalls.

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DateProductReasonClassFirm
Nov 20, 2020 HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/... The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... Class II Maquet Cardiovascular Us Sales, Llc
Nov 20, 2020 HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ... The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... Class II Maquet Cardiovascular Us Sales, Llc
Aug 26, 2020 EVOLVE STEM 8.5MM Model # 496S085 Lack of sterility assurance Class II Wright Medical Technology Inc
Aug 21, 2020 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged ... Lack of sterility assurance of the 30-0171 Class II North American Rescue LLC.
Aug 12, 2020 Central Line Dressing Change Tray Potential of incomplete seals impacting the sterility of the kit. Class II Medline Industries Inc
Aug 7, 2020 Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter ... Potential sterility issue Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in t... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab Kits failed sterility testing and showed evidence of contamination. Class II Gentueri Inc
May 27, 2020 Prodimed Combicath catheters for blind or fibrescope-guided protected distal ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath Paediatric catheters for blind protected distal bronchial ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath catheters for blind or fibrescope-guided protected distal ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath Paediatric catheters for blind protected distal bronchial ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 27, 2020 Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH ... Lack of assurance of sterility Class II Prodimed Plastimed Division
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Pro... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - P... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage:... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Pr... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max ... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max B... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quic... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3F... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Exte... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quic... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Sit... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pedia... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max B... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Mar 27, 2020 Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Ju... A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration... Class II Stryker Sustainability Solutions
Mar 17, 2020 Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 A... Sterility compromised due to packaging pouches that may not be sealed properly Class II Bard Peripheral Vascular Inc
Mar 13, 2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model ... There were unknown bioburden levels prior to sterilization, which may affect sterility of the pro... Class II Biomet, Inc.
Mar 9, 2020 Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... Medline identified that there may be a potential for voids in the packaging seal and loss of ster... Class II Medline Industries Inc
Feb 10, 2020 Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries 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.