Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 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 2,527 FDA device recalls in IN.

Date	Product	Reason	Class	Firm
Sep 26, 2024	KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph...	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in...	Class II	King Systems Corp. dba Ambu, Inc.
Sep 26, 2024	KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph...	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in...	Class II	King Systems Corp. dba Ambu, Inc.
Sep 26, 2024	KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph...	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in...	Class II	King Systems Corp. dba Ambu, Inc.
Sep 26, 2024	KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ...	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in...	Class II	King Systems Corp. dba Ambu, Inc.
Sep 26, 2024	KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr...	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in...	Class II	King Systems Corp. dba Ambu, Inc.
Sep 26, 2024	AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s...	Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in...	Class II	King Systems Corp. dba Ambu, Inc.
Sep 18, 2024	A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-enc...	The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge...	Class II	Polymer Technology Systems, Inc. dba PTS Diagno...
Sep 17, 2024	Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in mi...	A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in ...	Class II	Zimmer, Inc.
Sep 16, 2024	Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Or...	Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complain...	Class II	Cook Incorporated
Aug 15, 2024	Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-I...	Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 40...	Class II	Roche Diagnostics Operations, Inc.
Aug 7, 2024	Biodesign Fistula Plug C-FPS-0.4 - 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 Fistula Plug C-FPS-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 Recto-Vaginal Fistula Plug RVP-0.4 - 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-0.2-2 - 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 Fistula Plug C-FPB-0.4 - 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 Fistula Plug C-FPS-0.4-2 - 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 Fistula Plug C-FPS-0.2 - 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 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.

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.