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All recalls8,504 total

P
Philips North America Llc — IntelliVue Patient Monitor MX550. Product Number: 866066.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX750. Product Number: 866471.

Potential issue where the IntelliVue monitors did not alarm.

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Philips North America Llc — IntelliVue Patient Monitor MX450. Product Number: 866062.

Potential issue where the IntelliVue monitors did not alarm.

S
Stryker Corporation — NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

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Philips North America Llc — IntelliVue MP70. Product Number: M8007A.

Potential issue where the IntelliVue monitors did not alarm.

B
Blue Oven Bakery, Inc. — Blue Oven Artisan Bakery English Muffins, Net Wt. 13.4 oz (380g), packaged as a 4-pack in a clear plastic bag, UPC 198715684322

Undeclared allergen - milk

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Lotus Vaping Technologies, LLC — Monarch Premium Kratom Green Maeng Da powder is packaged in seal mylar pouches: Monarch Premium Kratom Green Maeng Da, 4oz powder (112g), UPC 851006008466 Monarch

Product has the potential to be contaminated with Salmonella

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Lotus Vaping Technologies, LLC — Monarch Premium Kratom White Elephant powder is packaged in seal mylar pouches: Monarch Premium Kratom, White Elephant, 4oz powder (112g), UPC 851006008480 Monarch P

Product has the potential to be contaminated with Salmonella

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Lotus Vaping Technologies, LLC — Monarch Premium Kratom Red Bali powder is packaged in seal mylar pouches: Monarch Premium Kratom Red Bali, 4oz powder (112g), UPC 851006008442 Monarch Premium Kratom

Product has the potential to be contaminated with Salmonella

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Lotus Vaping Technologies, LLC — Monarch Premium Kratom Bali Gold powder is packaged in seal mylar pouches: Monarch Premium Kratom Bali Gold, 4oz powder (112g), UPC 851006008428 Monarch Premium Krato

Product has the potential to be contaminated with Salmonella

C
Cepheid — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

O
Olympus Corporation of the Americas — Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

C
Cepheid — Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

I
Inpeco S.A. — FlexLab (FLX); Version: FLX-217-40;

The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes

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Inpeco S.A. — FlexLab (FLX); Version: FLX-217-10;

The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes.

J
JFE FRANCHISING INC — Peach Salsa - $5.99-16 oz 639123940636 packaged in clear plastic clamshells Sell by 11/3/2025 Sell by 11/4/2025

Peaches provided by Moonlight Peaches potentially contaminated with Listeria.

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GBC Food Services, LLC — Peach Salsa; UPC 85006540364 14oz (397g); Use by 10/12/2025 to 10/29/2025

Peaches provided by Moonlight Peaches potentially contaminated with Listeria.

A
Avion Pharmaceuticals, LLC — Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured

Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.

T
Triple B Corporation — COKE FARM Beans, Green 25 lb. Product of USA Coke Farm San Juan Bautista, CA 95045

Potential chemical contamination.

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Plenus Group Inc. — Rockport Lobser Bisque; packed in 2x8lb pouches and in 4x4b pouches

Products contain undeclared shrimp (crustacean shellfish)

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Siluetaya, LLC — SiluetaYa Mexican Tejocote Roots Supplement Pieces; 7g/bottle; Dietary Supplement, UPC#: 7500464462411, Lot: US1220 " Expiration Date: 06/2027

Product contains yellow oleander

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Otsuka ICU Medical LLC — POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-707

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

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Otsuka ICU Medical LLC — POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

B
B Braun Medical Inc — Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Lab

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista B

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista B

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. L

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pu

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. L

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

P
Philips North America Llc — CT 5300; Software Version Number: 4.5, 5.0, 5.1;

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista B

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Lab

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B
B Braun Medical Inc — IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basi

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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