Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number D
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827; f) PICC PACK, Model Number DYNJ65838; g) JVL-PACK PICC, Model Number DYNJ66062; h) FISTULAGRAM PACK, Model Number DYNJ66259; i) VEIN PACK-LF, Model Number DYNJ66271B; j) VEIN PACK
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number CVI4805; e) ED CENTRAL LINE KIT, Model Number CVI4865; f) NO CATH MIDLINE INSERTION KIT, Model Number CVI4950A; g) CENTRAL LINE PROCEDURE KIT, Model Number DT22260; h) ADULT EPIV INSERTION TRAY, Model Number DYNDA248
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TAVR PACK, Model Number DYNJ68499B; f) VEIN CLINIC, Model Number DYNJ68667; g) VASCULAR PACK, Model Number DYNJ68863; h) VASCULAR PACK, Model Number DYNJ68880; i) TAVR PACK, Model Number DYNJ68933; j) PROCEDURE PACK,
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DYNJ54153B; e) RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A; f) PEDI EP PACK, Model Number DYNJ54750G; g) EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C; h) LEE VEIN PACK, Model Number DYNJ54906B; i) HEART F
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ART
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Model Number DYNJ56547C; f) HYBRID, Model Number DYNJ57049G; g) HYBRID, Model Number DYNJ57049I; h) HYBRID, Model Number DYNJ57049J; i) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C; j) GENERAL ANGIO PACK, Model
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ03
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0160556D; e) VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AG; f) ANGIO PACK-LF, Model Number DYNJ0373279M; g) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121I; h) IPMC ANGIOGRAPHY PACK-LF, Model Number DYN
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRA
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881A; e) PAIN TRAY, Model Number DYNJRA1603; f) FEMORAL BLOCK TRAY, Model Number DYNJRA1739A; g) TAP BLOCK, Model Number DYNJRA1823; h) NERVE BLOCK PREP TRAY, Model Number DYNJRA1837; i) PAIN PREP TRAY
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceDiaSorin Molecular LLCClass IISimplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
- 2023-07-26FDA-DeviceDatascope Corp.Class ICardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
- 2023-07-26FDA-DeviceDatascope Corp.Class ICardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
- 2023-07-26FDA-DeviceDatascope Corp.Class ICardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
- 2023-07-26FDA-DeviceDatascope Corp.Class ICardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
- 2023-07-26FDA-DeviceBryan Medical IncClass IIAeris Balloon Dilation Catheter
Devices were mislabeled.
- 2023-07-26FDA-DeviceCardinal Health 200, LLCClass IINovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
- 2023-07-26FDA-DeviceAesculap Implant Systems LLCClass IIAesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
- 2023-07-26FDA-DeviceBeckman Coulter Biomedical GmbHClass IIBeckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
- 2023-07-26FDA-DeviceBeckman Coulter Biomedical GmbHClass IIBeckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
- 2023-07-26FDA-DeviceAbiomed, Inc.Class IImpella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
- 2023-07-26FDA-DeviceAbiomed, Inc.Class IImpella CP intravascular micro axial blood pump, Product Number 0048-0032
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
- 2023-07-26FDA-DeviceAbiomed, Inc.Class IImpella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
- 2023-07-26FDA-DeviceAbiomed, Inc.Class IImpella LD intravascular micro axial blood pump, Product Number 005082
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
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