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
Dec 15, 2015 Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. ... The cannulae may bend during procedure. Class II Globalmed Logistix
Dec 9, 2015 MOSAIQ Oncology Information System MOSAIQ is an oncology information syste... Incorrect drug dosage due to "Age Limit" and patient weight data item issue. Class II Elekta, Inc.
Nov 24, 2015 MOSAIQ Oncology Information System. Used to manage workflows for treatment... First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies dr... Class II Elekta, Inc.
Nov 10, 2015 Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling... Improper targeted temperature therapy was delivered to patients because the Temperature Simulator... Class II C.R. Bard, Inc.
Nov 9, 2015 Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The pr... The product may contain electronic components that lead to a premature drainage of the internal c... Class II C.R. Bard, Inc.
Oct 16, 2015 Monaco - Radiation Treatment Planning used to make treatment plans for patie... Unintended update of Dose and MU and Incorrect Assignment of Bolus. Class II Elekta, Inc.
Oct 2, 2015 Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold i... Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Cathet... Class III C.R. Bard, Inc.
Sep 15, 2015 Monaco Radiation Treatment Planning System. Used to make treatment plans f... Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple presc... Class II Elekta, Inc.
Aug 31, 2015 XiO Radiation Treatment Planning System. Used to create treatment plans for ... Incorrect Treatment Delivery Using Third Party Fixed Wedges. Class II Elekta, Inc.
Aug 24, 2015 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Ad... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Produc... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Produc... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Produ... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional T... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 1... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155);... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheos... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 227... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109)... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DS... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product ... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Pro... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Prod... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Co... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product C... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Prod... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); Ki... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product ... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); Kim... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Prod... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, D... The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning w... Class II Halyard Health, Inc
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the I... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 7, 2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, ... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jul 1, 2015 MOSAIQ Oncology Information System MOSAIQ is an oncology information system ... A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment mach... Class II Elekta, Inc.
Jun 12, 2015 On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement ... Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring ... Class II CryoLife, Inc.
Jun 1, 2015 Laksell GammaPlan, a computer based dose planning system specifically designe... Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2. Class II Elekta, 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.