Browse Device Recalls

706 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 706 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 706 FDA device recalls in GA.

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DateProductReasonClassFirm
Sep 26, 2025 AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium He... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004 Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium H... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Acti... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502 Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparin... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Acti... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium H... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503 Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium H... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium H... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fl... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium H... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings ... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium H... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Sep 26, 2025 SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diamet... Due to products manufactured under an inadequate quality system to include unvalidated manufactur... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Jul 17, 2025 Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Mode... Surgical drape packs may have open seals, which may compromise the sterility of the product. Class II O&M HALYARD INC
Jul 17, 2025 SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... Class II C.R. Bard Inc
Jul 17, 2025 SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Fol... Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... Class II C.R. Bard Inc
Jul 17, 2025 SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley ... Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber ... Class II C.R. Bard Inc
Jun 18, 2025 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated A... Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladde... Class II C.R. Bard Inc
Jun 3, 2025 BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr... Cather packaging may contain the incorrect French size. Class II C.R. Bard Inc
Jun 3, 2025 BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 1... Cather packaging may contain the incorrect French size. Class II C.R. Bard Inc
Jun 3, 2025 REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra Cather packaging may contain the incorrect French size. Class II C.R. Bard Inc
Jun 2, 2025 Medshape Universal Joints, REF: DNE-9000-UJ Bone external fixation system may have the pin that can become dislodged resulting in frame insta... Class II Medshape, INC.
May 5, 2025 SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassiu... All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to ... Class II ASP Global, LLC. dba Anatomy Supply Partners, LLC.
Apr 17, 2025 Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. ... Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 17, 2025 Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 Due to customer complaints, there is a potential for users to be unable to or find it difficult t... Class I C.R. Bard Inc
Apr 13, 2025 Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit R... Due to non-sterile products being labeled as sterile Class II Microtek Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Mar 19, 2025 Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... Lack of sterility assurance for closed suction catheter systems Class I Avanos Medical, Inc.
Feb 3, 2025 CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital S... Due to issues associated with data migration of patient information and results to a Cloud servic... Class II St. Jude Medical
Jan 15, 2025 MOSAIQ Oncology Information System Image offsets calculated by oncology Information System software may be incorrect for Linear A... Class II Elekta, Inc.
Nov 6, 2024 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN... Due to a data migration from on-premises server to the cloud environment, some customers reported... Class II St. Jude Medical
Oct 31, 2024 Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US... Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurr... Class II Cartiva, 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.