Medical Device Recalls

7,870 medical device recalls from federal enforcement feeds.

Showing 351–400 of 7,870

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B;

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

  Class I

• Medical Device Recall · April 10, 2026

  ARROW INTERNATIONAL, LLC

  Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE,

  16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  ARROW INTERNATIONAL, LLC

  NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialy

  16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJ

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

  Class I

• Medical Device Recall · April 10, 2026

  ARROW INTERNATIONAL, LLC

  Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplici

  16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Medline Industries, LP

  Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817;

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 10, 2026

  ARROW INTERNATIONAL, LLC

  Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

  16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

  Class I

• Medical Device Recall · April 10, 2026

  Stryker Sustainability Solutions

  BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

  Incomplete seals on sterile product

  Class II

• Medical Device Recall · April 9, 2026

  Stryker Corporation

  Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irri

  Due to nonconforming products being inadvertently distributed.

  Class II

• Medical Device Recall · April 8, 2026

  Becton, Dickinson and Company

  Swan-Ganz Pacing Catheter, Models: D200F7;

  Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

  Class II

• Medical Device Recall · April 8, 2026

  Becton, Dickinson and Company

  Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;

  Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

  Class II

• Medical Device Recall · April 8, 2026

  Hologic, Inc

  SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2,

  Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

  Class II

• Medical Device Recall · April 8, 2026

  Hologic, Inc

  3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-N

  Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

  Class II

• Medical Device Recall · April 8, 2026

  Becton, Dickinson and Company

  Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

  Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

  Class II

• Medical Device Recall · April 8, 2026

  Medtronic Neuromodulation

  Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B

  Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

  Class II

• Medical Device Recall · April 7, 2026

  Becton Dickinson & Co.

  BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

  BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

  Class II

• Medical Device Recall · April 7, 2026

  Becton Dickinson & Co.

  BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

  BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

  Class II

• Medical Device Recall · April 6, 2026

  Stryker Neurovascular

  INZONE DETACHMENT SYSTEM, REF: M00345100950

  Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

  Class II

• Medical Device Recall · April 6, 2026

  Quidel Corporation

  QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

  Product has the potential for false positive results

  Class II

• Medical Device Recall · April 6, 2026

  MICROVENTION INC.

  LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

  Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events

  Class II

• Medical Device Recall · April 3, 2026

  Grace Medical, Inc.

  TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

  Due to incorrect functional length on device labeling.

  Class II

• Medical Device Recall · April 3, 2026

  DEPUY (IRELAND)

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

  Class II

• Medical Device Recall · April 3, 2026

  DEPUY (IRELAND)

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

  Class II

• Medical Device Recall · April 3, 2026

  DEPUY (IRELAND)

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

  Class II

• Medical Device Recall · April 3, 2026

  DEPUY (IRELAND)

  Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

  The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

  Class II