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.
- 2024-04-24FDA-DeviceCook IncorporatedClass IIEntuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2024-04-24FDA-DeviceCook IncorporatedClass IIPeel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2024-04-24FDA-DeviceCook IncorporatedClass IIYueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2024-04-24FDA-DeviceCook IncorporatedClass IITrocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2024-04-24FDA-DeviceCook IncorporatedClass IIChiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2024-04-24FDA-DeviceBaxter Healthcare CorporationClass IISurgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 745202
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
- 2024-04-24FDA-DeviceBaxter Healthcare CorporationClass IISurgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300,
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
- 2024-04-24FDA-DeviceBaxter Healthcare CorporationClass IISurgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BI
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
- 2024-04-24FDA-DeviceSonarMed IncClass IAW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
- 2024-04-24FDA-DeviceSonarMed IncClass IAW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
- 2024-04-24FDA-DeviceSonarMed IncClass IAW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
The failure to detect the partial obstruction in a 2.5mm sensor.
- 2024-04-24FDA-DeviceDraeger Medical, Inc.Class IDr¿ger Perseus A500 Anesthesia Workstation
Unexpected shutdown while operating on battery power.
- 2024-04-24FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DevicePhilips Respironics, Inc.Class ITrilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DevicePhilips Respironics, Inc.Class ITrilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DevicePhilips Respironics, Inc.Class ILifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DevicePhilips Respironics, Inc.Class IGarbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DevicePhilips Respironics, Inc.Class IAeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- 2024-04-24FDA-DeviceOutset Medical, Inc.Class ITablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.
- 2024-04-24FDA-DeviceElekta Instrument ABClass IElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
- 2024-04-17FDA-DeviceIntuitive Surgical, Inc.Class IIPatient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
- 2024-04-17FDA-DeviceBoston Scientific CorporationClass IIEndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- 2024-04-17FDA-DeviceBoston Scientific CorporationClass IIEndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00568211
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- 2024-04-17FDA-DeviceBoston Scientific CorporationClass IIEndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00566471
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- 2024-04-17FDA-DeviceBoston Scientific CorporationClass IIEndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509051
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- 2024-04-17FDA-DeviceBoston Scientific CorporationClass IIEndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509011
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- 2024-04-17FDA-DeviceBaxter Healthcare CorporationClass IIPower Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD,AUSTRALIA,2.5A,250V,2.5M,C7, 008-0910-00; e) POWER CORD,EUROPEAN,2.5A,250V,2.5M,C7, 008-0912-00; f) LINE CORD (EURO), 4500-402; g) LINE CORD (UK), 4500-404; h) LINE CORD (AUS), 4500-406
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- 2024-04-17FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CASE,PLUG2/EUR, VS100S-2; e) SPOT VISION SCREENER,W/CASE,PLUG4/UK, VS100S-4; f) SPOT VISION SCREENER,W/CASE,PLUG7/SA, VS100S-7; g) SPOT VISION SCREENER W/CASE, BRAZIL, VS100S-Z; h) SPOT VS POWER SUPPLY SET/PLUG2/EUR
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- 2024-04-17FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,AU, Product Code 34BFST-6; d) PROBP 3400, BLUETOOTH, MOBILE, EU, Product Code 34BXST-2; e) PROBP 3400, BLUETOOTH, MOBILE, UK, Product Code 34BXST-4; f) PROBP 3400, BLUETOOTH, MOBILE, ZA, Product Code 34BX
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
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