Browse Device Recalls

2,560 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,560 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 2,560 FDA device recalls in IN.

Clear
DateProductReasonClassFirm
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissu... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue ... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Aug 7, 2024 Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in th... Products expire prior to the expiration date printed on the product labeling Class II Cook Biotech, Inc.
Jul 2, 2024 CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip... Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). T... Class II Zimmer, Inc.
May 17, 2024 RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hi... 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to jo... Class II Biomet, Inc.
May 15, 2024 Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 15, 2024 Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-... Product labels state the incorrect expiration dates that extends beyond their true expiration date Class II Cook Incorporated
May 13, 2024 Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... Class II Roche Diabetes Care, Inc.
Apr 12, 2024 APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used w... Screw is 16mm long instead of 22mm long. Class II Medartis Inc.
Apr 5, 2024 WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedi... The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titan... Class II Wishbone Medical, Inc.
Apr 1, 2024 EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 Devices may contain elevated levels of bacterial endotoxin. Class II Cook Medical Incorporated
Apr 1, 2024 EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 Devices may contain elevated levels of bacterial endotoxin. Class II Cook Medical Incorporated
Mar 28, 2024 NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of ... Out of specification violation of devices that results in a gap existing within the fixture that ... Class II Zimmer, Inc.
Mar 25, 2024 AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to ... Class I SonarMed Inc
Mar 21, 2024 AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 21, 2024 AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor ... The failure to detect the partial obstruction in a 2.5mm sensor. Class I SonarMed Inc
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indic... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated f... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indica... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indica... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 20, 2024 ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... Thread form issue for the locking holes in that the locking screws may not properly mate with the... Class II Zimmer, Inc.
Mar 13, 2024 Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... Class II Biomet, Inc.
Mar 12, 2024 ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... Product incorrectly labelled. Class II DePuy Orthopaedics, Inc.
Mar 1, 2024 Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (R... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator With AQ Hydrophilic Coating - Intended to be used for dilating punctu... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts f... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Trocar Needle - Used for dilating puncture sites or catheter tracts for percu... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous f... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for an... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Dilator - Intended to be used for dilating puncture sites or catheter tracts ... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated
Mar 1, 2024 Peel-Away Introducer - Intended for the percutaneous introduction of balloon,... Packaging may have low seal strength and not meet peel strength specifications, compromising devi... Class II Cook Incorporated

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.