Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-11-06FDA-DeviceHycor Biomedical LLCClass IIHYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
- 2019-11-06FDA-DeviceSynthes (USA) Products LLCClass IISynapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
The subject product measures 4.0mm in diameter instead of 3.5mm.
- 2019-11-06FDA-DeviceMedical Components, Inc dba MedCompClass IIC3 Wave App, v. 2.0.5
When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.
- 2019-11-06FDA-DeviceThoratec Switzerland GMBHClass ICentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
- 2019-11-06FDA-DeviceLivaNova USA Inc.Class IISORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volu
The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.
- 2019-11-06FDA-DeviceOrthoPediatrics CorpClass IIModel No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
- 2019-11-06FDA-DeviceOrthoPediatrics CorpClass IIModel No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
- 2019-11-06FDA-DeviceEthicon Endo-Surgery IncClass IECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
- 2019-11-06FDA-DeviceEthicon Endo-Surgery IncClass IECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
- 2019-11-06FDA-DeviceEthicon Endo-Surgery IncClass IECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
- 2019-11-06FDA-DeviceEthicon Endo-Surgery IncClass IECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
- 2019-11-06FDA-DeviceValeritas, IncorporatedClass IIDEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
There is a potential for "No Needle Demo Units" to contain a needle.
- 2019-11-06FDA-DeviceValeritas, IncorporatedClass IIDEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
There is a potential for "No Needle Demo Units" to contain a needle.
- 2019-11-06FDA-DeviceValeritas, IncorporatedClass IIDEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
There is a potential for "No Needle Demo Units" to contain a needle.
- 2019-11-06FDA-DeviceValeritas, IncorporatedClass IIDEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
There is a potential for "No Needle Demo Units" to contain a needle.
- 2019-11-06FDA-DeviceValeritas, IncorporatedClass IIDEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
There is a potential for "No Needle Demo Units" to contain a needle.
- 2019-11-06FDA-DeviceTIDI PRODUCTSClass IIPosey Connected Twice-As-Tough Cuffs
Not meeting design specifications.
- 2019-10-30FDA-DeviceCrossRoads Extremity Systems, LLCClass IIMotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.
- 2019-10-30FDA-DeviceBeckman Coulter Inc.Class IIBeckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
- 2019-10-30FDA-DeviceBeckman Coulter Inc.Class IIBeckman Coulter Lipase, REF OSR6130 and OSR6230.
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
- 2019-10-30FDA-DeviceCandela CorporationClass IICanister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
- 2019-10-30FDA-DeviceCandela CorporationClass IICanister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
- 2019-10-30FDA-DeviceCandela CorporationClass IICanister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
- 2019-10-30FDA-DeviceCandela CorporationClass IICanister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
- 2019-10-30FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
- 2019-10-30FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
- 2019-10-30FDA-DeviceBecton Dickinson & CompanyClass IIBD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer¿ Push Button Blood Collection Set with the needle protector removed prior to needle retraction.
Separation of front and rear barrels upon activation of the safety feature that retracts the needle
- 2019-10-30FDA-DeviceArrow International IncClass IIArrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor i
Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length
- 2019-10-30FDA-DeviceIrriMAX CorporationClass IIIrrisept Wound Debridement and Cleansing System. 12 units per case.
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
- 2019-10-30FDA-DeviceSmiths Medical ASD Inc.Class IIGRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA;
Potential for certain GRIPPER Needles to contain an occluded or blocked needle.
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