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All recalls7,869 total

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lbs. UPC 731149654075. Product was sold at WinCo.

Shrimp may be contaminated with Cesium-137 (Cs-137).

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25, net wt. 2lbs., UPC 021130123223. Product was sold at Shaw s and Star Market, Albertso

Shrimp may be contaminated with Cesium-137 (Cs-137).

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — AquaStar 13/15 Raw Shrimp Easy Peel Deveined, net wt. 2 lbs. UPC 731149654051. Product was sold at Publix.

Shrimp may be contaminated with Cesium-137 (Cs-137).

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — Publix Large Shrimp Peeled & Deveined Tail On 31/40, net wt. 1.5 lbs. UPC 041415067455. Product was sold at Publix.

Shrimp may be contaminated with Cesium-137 (Cs-137).

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — Publix Extra Large Shrimp Easy to Peel Deveined 21/25, net wt. 1.5 lbs. UPC 041415064454. Product was sold at Publix.

Shrimp may be contaminated with Cesium-137 (Cs-137).

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — AquaStar Raw Peeled Tail-on Shrimp Skewers, net wt. 1.25lbs. UPC 731149390010. Product is packaged in a printed bag with a black top and blue

Shrimp may be contaminated with Cesium-137 (Cs-137).

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — Kroger Raw Colossal EZ Peel Shrimp, net wt. 2lbs., UPC 20011110643906. Product is packaged in transparent printed bag with a blue band on the

Shrimp may be contaminated with Cesium-137 (Cs-137).

A
Admiralty Island Fisheries Inc dba AquaStar (USA) Corp. — Best Yet Frozen Raw EZ-Peel White Shrimp 16/20 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700282 Best Yet Frozen Raw EZ-Peel White Shri

Shrimp may be contaminated with Cesium-137 (Cs-137).

B
Black Sheep Egg Company, LLC — Free Range Grade A Large Brown Eggs, 12ct Cartons, UPC: 860010568507, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Medium Brown Eggs, Loose Pack in Boxes, 15dz per box, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Medium White Eggs, Loose Open Skid, 900dz per pallet, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Large Brown Eggs, Loose Open Skid, 900dz per pallet, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Large White Eggs, 12ct Cartons, 15dz per box, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Large White Eggs, Loose Open Skid, 900dz per pallet, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade A Large Brown Eggs, 18ct Cartons, UPC: 860010568538, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Medium White Eggs, 18ct Cartons, 15dz per box, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Medium Brown Eggs, Loose Open Skid, 900dz per pallet, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

B
Black Sheep Egg Company, LLC — Free Range Grade AA Large Brown Eggs, Loose Pack in Boxes, 15dz per box, Black Sheep Egg Company 400 S Memorial Drive Walnut Ridge AR 72476

Potential Salmonella contamination.

A
Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distribut

Failed Dissolution Specifications

A
Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem

Failed Dissolution Specifications

A
Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Man

Failed Dissolution Specifications

A
Ascend Laboratories, LLC — Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: A

Failed Dissolution Specifications

K
Kico Knee Innovation Company — Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Int

Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

B
Beckman Coulter, Inc. — DxI 9000 Access Immunoassay Analyzer, Part Number C11137

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

O
Orthofix U.S. LLC — Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-107

Polyaxial screws do not meet performance standards.

B
Beckman Coulter, Inc. — DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Par

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

E
Egress Capital Partners Inc. — Taproom Gourmet brand 20lb and 18lb bulk "Fifth Avenue" Mix

No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashew, and soy)

E
Egress Capital Partners Inc. — Taproom Gourmet brand 15lb bulk "Madison" Mix

No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)

E
Egress Capital Partners Inc. — Taproom Gourmet brand 15lb bulk "Broadway" Mix

No ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)

E
Egress Capital Partners Inc. — Taproom Gourmet brand 20lb bulk "Park" Mix

No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashews, wheat, soy, and sesame)

E
Egress Capital Partners Inc. — Taproom Gourmet brand 18lb bulk "Empire" Mix

No ingredient label. Product contains undeclared allergens (cashews, almonds, walnuts, Brazil nuts, pecans, pistachios)

G
Goyal Group Inc. — 1. SILVER HORSE - PURE ALUMINIUM MADE IN INDIA - ALUMINIUM MILK PAN 4 inches 2. SILVER HORSE - ALUMINIUM MATHAR KADAI - 26 inches

Contains elevated levels of lead

G
Garden Fresh Foods, Inc. — Sliced (1/4") green onions, refrigerated, packaged in plastic bag. Each case consist 5/6lbs. bag (net wt. 30lbs.). Garden Fresh Foods Inc. Woodinville, WA. Product is dist

Possible positive Listeria monocytogenes. Firm tested one lot of sliced green onions in-house and found Listeria monocytogenes.

W
Western United Fish Company Inc — Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco #17193, net wt. 1lb. Product is packaged in clear plastic clamshell container and sold to consumers.

Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke.

C
Cardinal Health 200, LLC — Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Sale

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

G
GE Medical Systems, LLC — LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

B
B BRAUN MEDICAL INC — PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Cathe

Potential for the lid of the catheter connector to be in the incorrect position.

C
Cardinal Health 200, LLC — Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

C
Cardinal Health 200, LLC — Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tub

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

B
B BRAUN MEDICAL INC — Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PE

Potential for the lid of the catheter connector to be in the incorrect position.

B
B BRAUN MEDICAL INC — Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX

Potential for the lid of the catheter connector to be in the incorrect position.

B
B BRAUN MEDICAL INC — PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Cathet

Potential for the lid of the catheter connector to be in the incorrect position.

B
B BRAUN MEDICAL INC — ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Ce

Potential for the lid of the catheter connector to be in the incorrect position.

B
B BRAUN MEDICAL INC — Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 2007

Potential for the lid of the catheter connector to be in the incorrect position.

C
Cardinal Health 200, LLC — Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

C
Cook Medical Incorporated — Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

B
B BRAUN MEDICAL INC — PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Produ

Potential for the lid of the catheter connector to be in the incorrect position.

A
Abbott Laboratories — Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Des

Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

F
Fisher & Paykel Healthcare, Ltd. — Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.

B
B BRAUN MEDICAL INC — Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK M

Potential for the lid of the catheter connector to be in the incorrect position.

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