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All recalls8,504 total

F
First & Last Tavern — First & Last Tavern Puttanesca Sauce (olives, capers, hot peppers) 26 FL OZ (1 lb, 10 oz) 737g

May be contaminated with Clostridium botulinum

I
INDIAN COOKWARE AND APPLIANCE LLC — ALUMINIUM HAMMERED KADAI SIZE 7 8 901000 000057 MADE IN INDIA

Potential contamination due to leachable lead.

F
First & Last Tavern — First & Last Tavern Traditional Pasta Sauce (meat flavored) 26 FL OZ (1 lb., 10 oz) 737g

May be contaminated with Clostridium botulinum

B
Blossom Pharmaceuticals — Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauder

cGMP deviations

B
Blossom Pharmaceuticals — Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacram

cGMP deviations

B
Blossom Pharmaceuticals — Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.

cGMP deviations

B
Blossom Pharmaceuticals — Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Car

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Car

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.

cGMP deviations

C
Cipla Limited — Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, In

Failed Stability Specifications: Observed OOS results: eg results for colour index

B
Blossom Pharmaceuticals — Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Phar

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.

cGMP deviations

B
Blossom Pharmaceuticals — Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 3

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, M

Defective container: cracked/broken cartridges

N
Novocol Pharmaceutical of Canada, Inc. — Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml eac

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.

cGMP deviations

B
Blossom Pharmaceuticals — WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.

cGMP deviations

P
Philips North America Llc — IntelliVue Patient Monitor MX800. Product Number: 865240.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP90. Product Number: M8010A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP30. Product Number: M8002A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips Ultrasound, LLC — Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

P
Philips North America Llc — IntelliVue Patient Monitor MX700. Product Number: 865241.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue Patient Monitor MX500. Product Number: 866064.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue Patient Monitor MX850. Product Number: 866470.

Potential issue where the IntelliVue monitors did not alarm.

S
Stryker Corporation — NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook

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

S
Stryker Corporation — NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-80

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

P
Philips North America Llc — IntelliVue MP2. Product Number: M8102A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP50. Product Number: M8004A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP80. Product Number: M8008A.

Potential issue where the IntelliVue monitors did not alarm.

A
Aizu Olympus Co., Ltd. — Olympus OER-Elite

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

A
Aizu Olympus Co., Ltd. — Olympus OER-Mini

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

P
Philips North America Llc — IntelliVue Patient Monitor MX100. Product Number: 867033.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP40. Product Number: M8003A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue Multi Measurement Server X2. Product Number: M3002A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP60. Product Number: M8005A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP5. Product Number: M8105A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue MP20. Product Number: M8001A.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue Patient Monitor MX600. Product Number: 865242.

Potential issue where the IntelliVue monitors did not alarm.

S
Stryker Medical Division of Stryker Corporation — Stryker Arise 1000EX mattress, Part Number 2236000000

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

S
Stryker Medical Division of Stryker Corporation — Stryker MV3 bariatric bed, Part Number 5900000001

Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

P
Philips North America Llc — IntelliVue Patient Monitor MX400. Product Number: 866060.

Potential issue where the IntelliVue monitors did not alarm.

P
Philips North America Llc — IntelliVue Multi-Measurement Module X3. Product Number: 867030.

Potential issue where the IntelliVue monitors did not alarm.

A
Aizu Olympus Co., Ltd. — Olympus OER-Pro

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

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