Recall

All recalls8,501 total

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Medline Industries, LP — Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

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B Braun Medical Inc — Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GO

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

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Medline Industries, LP — Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL AND ARTERIAL LINE TOTE, Model Number: DYNJ8407

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

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Medline Industries, LP — Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

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Fresenius Kabi USA, LLC — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

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Fresenius Kabi USA, LLC — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.

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B Braun Medical Inc — Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORI

These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

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Jesse Withrow — My Wife's Slaw Jalapeno Heat, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands, MyWifeslaw.web.app, Zanesville, Ohio. Ingredients: Cabbage, Sugar, Vinegar, Mustard,

Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.

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Jesse Withrow — My Wife's Slaw, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands, MyWifeslaw.web.app, Zanesville, Ohio. Ingredients: Cabbage, Sugar, Vinegar, Mustard, Carrots, Onion

Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.

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Olympus Corporation of the Americas — Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

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Olympus Corporation of the Americas — Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

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Olympus Corporation of the Americas — Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

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Olympus Corporation of the Americas — Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

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Market of Choice Inc — Market of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged into a clear flexible plastic clamshell container. Label has UPC 0 210126 01099 3. Mark

Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame.

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D'Dioses Fruit Pops, Inc. — Ice Pop, D'Dioses Nuez, 1 Bar (81.7 g), with UPC 827912008548

May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Med

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPI

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of product

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Micromed S.p.A. — SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSC

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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KAYSERBETTEN GMBH & CO. KG — Pediatric care bed; Product Designation: KayserBett IDA;

If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).

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Medline Industries, LP — MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (REF) URO4RR16C

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) UR

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN M

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP,

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND135

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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Medline Industries, LP — MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU (REF) DYND18350

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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