Product Recall Checker | Search Product Recalls by UPC, Lot Code, Brand or Model

Latest Product Recall Matches

Showing 776 - 800 of 4,622 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080 The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.	FDA Z-3122-2026	Medical Device	High	Sep 23, 2026 Recall: Aug 11, 2026	Details
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.	FDA Z-3166-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 31, 2026	Details
IV Non-Dedicated Gravity Administration Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.	FDA Z-3157-2026	Medical Device	High	Sep 23, 2026 Recall: May 12, 2026	Details
TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene) Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.	FDA Z-3204-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 30, 2026	Details
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene) Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.	FDA Z-3196-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 30, 2026	Details
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.	FDA Z-3126-2026	Medical Device	High	Sep 23, 2026 Recall: Aug 11, 2026	Details
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 4. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 5. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.	FDA Z-3149-2026	Medical Device	High	Sep 23, 2026 Recall: Aug 12, 2026	Details
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS); The packaging may not consistently maintain sterile barrier integrity.	FDA Z-3144-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 31, 2026	Details
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).	FDA Z-3177-2026	Medical Device	High	Sep 23, 2026 Recall: Aug 20, 2026	Details
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT; Some devices may not have been properly sterilized due to a manufacturing sterilization issue.	FDA Z-3147-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 31, 2026	Details
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US Transfemoral catheter, positing arm may detached due to weld issue.	FDA Z-3213-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 6, 2026	Details
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.	FDA Z-3168-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 31, 2026	Details
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM Reusable access port system may crack or seperate during use.	FDA Z-3186-2026	Medical Device	High	Sep 23, 2026 Recall: Aug 19, 2026	Details
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRA Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.	FDA Z-3201-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 30, 2026	Details
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.	FDA Z-3199-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 30, 2026	Details
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154; Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.	FDA Z-3193-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 20, 2026	Details
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM Reusable access port system may crack or seperate during use.	FDA Z-3187-2026	Medical Device	High	Sep 23, 2026 Recall: Aug 19, 2026	Details
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-41110; 15mm x 12mm/152-41512; 18mm x 18mm/152-41818; 20mm x 20mm/152-42020 Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.	FDA Z-3211-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 15, 2026	Details
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene) Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.	FDA Z-3206-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 30, 2026	Details
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.	FDA Z-3121-2026	Medical Device	High	Sep 23, 2026 Recall: Aug 11, 2026	Details
Philips PIC iX Essentials REF:867093 Due to software malfunction, patient information system may freeze and become unresponsive.	FDA Z-3142-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 31, 2026	Details
IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.	FDA Z-3161-2026	Medical Device	High	Sep 23, 2026 Recall: May 12, 2026	Details
Plum administration sets Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.	FDA Z-3156-2026	Medical Device	High	Sep 23, 2026 Recall: May 12, 2026	Details
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.	FDA Z-3128-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 29, 2026	Details
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.	FDA Z-3130-2026	Medical Device	High	Sep 23, 2026 Recall: Jul 29, 2026	Details

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