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All recalls8,508 total

N
Newly Weds Foods, Inc. — Newly Weds B61610-BREAD CRUMBS X1-NET WT 45 LBS

potential Listeria Monocytogenes Contamination

N
Newly Weds Foods, Inc. — Newly Weds B57569 BREADER X1- NEW WT 25 LBS.

potential Listeria Monocytogenes Contamination

N
Newly Weds Foods, Inc. — Newly Weds B6AAK3-BREAD CRUMBS X1-NET WT 35LBS

potential Listeria Monocytogenes Contamination

N
Newly Weds Foods, Inc. — Newly Weds A60647- BREAD CRUMBS X1-NET WT 35 LBS.

potential Listeria Monocytogenes Contamination

N
Newly Weds Foods, Inc. — Newly Weds B61453-BREAD CRUMBS X1-NET WT 25 LBS

potential Listeria Monocytogenes Contamination

N
Newly Weds Foods, Inc. — Newly Weds B60960-BREAD CRUMBS X1-NET WT 6 LBS

potential Listeria Monocytogenes Contamination

N
Newly Weds Foods, Inc. — Newly Weds A93060 BREADER X1- NEW WT 40 LBS.

potential Listeria Monocytogenes Contamination

B
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit

S
Stryker Communications — Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

W
Waldemar Link GmbH & Co. KG (Mfg Site) — Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

Inconsistent size terminology and color coding used on labeling

W
Waldemar Link GmbH & Co. KG (Mfg Site) — Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

Inconsistent size terminology and color coding used on labeling

A
American Contract Systems Inc — AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER C

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

M
MAQUET GMBH — Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.

Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.

B
Baxter Healthcare Corporation — Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

M
MEDLINE INDUSTRIES, LP - Northfield — Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH,

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

A
American Contract Systems Inc — AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Num

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

B
Baxter Healthcare Corporation — Spectrum IQ Infusion Pump, Product Code 3570009

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

D
Dollar General Corporation — Twister Fruit Punch, 59 FL OZ (1.84 QT) 1.75 L, packaged in a paper carton, UPC: 048500021231

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Milo's Famous Sweet Tea, 128 FL OZ (1 GAL) 3.78 L, packaged in a plastic jug, UPC: 091475511009

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Minute Maid Tropical Punch, 59 FL OZ (1.8 QT) 1.75 L, packaged in a paper carton, UPC: 025000047695

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Clover Valley Lactose Free 2% Reduced Fat Milk, 64 FL OZ (2 QTS) 1.89 L, packaged in a paper carton, UPC: 070744010085

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Pillsbury Cinnamon Rolls Original Icing, 8 ct., NET WT 12.4 OZ (351g), packaged in a cardboard and aluminum tube, UPC: 018000005017

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Silk Vanilla AlmondMilk, 64 FL OZ (2 QT) 1.89 L, packaged in a paper carton, UPC: 025293000995

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Yoplait Original Harvest Peach Yogurt, 6 OZ (170g), packaged in a plastic cup, UPC: 170470003075

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Shamrock Farms Whole Milk, 12 FL OZ (354 ML), packaged in a plastic bottle, UPC: 028300000896

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Minute Maid Fruit Punch, 59 FL OZ (1.8 QT) 1.75 L, packaged in a paper carton, UPC: 025000047732

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Yoplait Original Strawberry Banana Yogurt, 6 OZ (170g), packaged in a plastic cup, UPC: 170470003136

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Velveeta Slices Sharp Cheddar, 16 ct., NET WT 12 OZ (340g), packaged in plastic/cardboard, UPC: 021000044894

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Shamrock Farms Chocolate Rockin' Protein Builder Protein Shake, 12 FL OZ (354 ML), packaged in a plastic bottle, UPC: 028300004054

Temperature abuse due to temperature excursion in one shipping trailer

N
NuNaturals Inc — Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187 6. Product is packaged in a plastic bottle with white cap. Ingredient: Monk Fruit (Luo Han Guo) Extract. Monk Fruit is so

Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.

D
Dollar General Corporation — 1) Clover Valley Vitamin D Whole Milk, 1 GAL (3.78 L), packaged in a plastic jug, UPC: 070744002196 2) Clover Valley Vitamin D Whole Milk, 1/2 GAL (1.89 L), packaged in a

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Chobani Vanilla Greek Yogurt, 4 OZ (113g), packaged in a plastic cup, UPC: 818290010322

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Milo's Lemonade, 128 FL OZ (1 GAL) 3.78 L, packaged in a plastic jug, UPC: 091475519005

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Imperial 48% Vegetable Oil Spread Margarine Sticks, NET WT 16 OZ (1 LB) 453g, packaged in a cardboard box, UPC: 011115871324

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Clover Valley 1% Low Fat Chocolate Milk, 1/2 GAL (1.89 L), packaged in a plastic jug, UPC: 070744009942

Temperature abuse due to temperature excursion in one shipping trailer

O
OHIO HEALTH MOTHER MILK BANK — 1) OH MMB Human Donor Milk, 20.00 Cal/oz, 1.00 g/dl Protein, packaged in 3 oz plastic bottles 2) OH MMB Human Donor Milk, 20.00 Cal/oz, 0.80 g/dl Protein, packaged in 6

Inaccurate temperature reading from a thermometer on one pasteurization machine

W
World Market Management Services, LLC — Dubai emek SPREAD PISTACHIO CACAO CREAM WITH KADAYIF NET WT. 9.7oz UPC 8 69652 10130 1 Manufacturer: Emek Dogal Saglik Urunlerilkl. Gida Turkey

Salmonella. The firm was notified by the FDA that the product may be contaminated with Salmonella.

D
Dollar General Corporation — Checkers Famous Seasoned Fries, NET WT 28 OZ (1 LB 12 OZ) 793g, packaged in a plastic/vinyl bag, UPC: 043301305818

Temperature abuse due to temperature excursion in one shipping trailer

N
NuNaturals Inc — Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Product is packaged in a plastic bottle with white cap. Ingredient: Organic Stevia Extract. Sprinkle a pinch for the perfect sw

Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.

D
Dollar General Corporation — Clover Valley One Dozen Grade A Eggs Large, 12 ct, packaged in styrofoam, UPC: 077438599024

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Chobani Flip Cookie Dough Greek Yogurt, NET WT. 4.5 OZ (128g), packaged in a plastic cup, UPC: 818290016652

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — 1) Clover Valley 2% Reduced Fat Milk, 1 GAL (3.78 L), packaged in a plastic jug, UPC: 070744002202 2) Clover Valley 2% Reduced Fat Milk, 1/2 GAL (1.89 L), packaged in a pl

Temperature abuse due to temperature excursion in one shipping trailer

B
BUNGE NORTH AMERICA INC — NH EUROPEAN STYLE BUTTER BLEND, BUNGE, NET WT 1 LB, MFD IN USA BY: Bunge Oils, Chesterfield, MO 63017, packed in white paperboard cases (36 blocks to a case) OW NH EURO BLEND

allergen labeling - undeclared milk

D
Dollar General Corporation — Clover Valley Shredded Parmesan Cheese, NET WT 6 OZ (170g), packaged in a plastic bag, UPC: 071505950428

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — 1) Simply Orange Pulp Free Orange Juice, 46 FL OZ (1.4 QT) 1.36 L, packaged in a plastic bottle, UPC: 025000136788 2) Simply Orange Pulp Free Orange Juice, 11.5 FL OZ (340

Temperature abuse due to temperature excursion in one shipping trailer

D
Dollar General Corporation — Milo's Extra Sweet Tea, 128 FL OZ (1 GAL) 3.78 L, packaged in a plastic jug, UPC: 091475931982

Temperature abuse due to temperature excursion in one shipping trailer

A
American Contract Systems Inc — AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798),

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

A
American Contract Systems Inc — AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM N

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

A
American Contract Systems Inc — AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

A
American Contract Systems Inc — AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J;

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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