Browse Device Recalls

672 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 672 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 672 FDA device recalls in GA.

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DateProductReasonClassFirm
Feb 6, 2026 Artelon FlexBand Plus Ref: 41054 & 41057 Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 6, 2026 Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) ... Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Feb 6, 2026 Artelon FlexBand Dynamic Matrix Ref: 31057 Augmentation devices failed bacterial endotoxin testing. Class II International Life Sciences
Jan 14, 2026 PIE Trolley System Model: 2005 Lack of 510K clearance Class II Edermy LLC
Jan 14, 2026 PIE PAK Models: P2HC-A, P2HC-S, P2HC Lack of 510K clearance Class II Edermy LLC
Dec 14, 2025 Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, ... Due to a manufacturing issue and electrical grounding of systems. Class II Elekta, Inc.
Dec 12, 2025 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni... Due to an error when defining a new stereotactic reference that users fail to first change an alr... Class II Elekta, Inc.
Dec 12, 2025 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni... Due to an error when defining a new stereotactic reference that users fail to first change an alr... Class II Elekta, Inc.
Dec 10, 2025 MOSAIQ Oncology Information System with Particle Therapy License (License Ki... Using oncology information system that manages workflow may result in overtreatment if:Plan deliv... Class II Elekta, Inc.
Nov 6, 2025 BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit R... Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class II C.R. Bard Inc
Nov 6, 2025 BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit ... Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class II C.R. Bard Inc
Nov 6, 2025 Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class II C.R. Bard Inc
Nov 6, 2025 BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit R... Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class II C.R. Bard Inc
Sep 30, 2025 Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereo... Due to increased risk that paint flakes from the engravings may separate from the device and ther... Class II Elekta, Inc.
Sep 26, 2025 SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿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, 200 ¿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 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

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.