Recall

All recalls7,869 total

A
Amneal Pharmaceuticals, LLC — chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213,

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

A
Amneal Pharmaceuticals, LLC — chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

A
Amneal Pharmaceuticals, LLC — chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213,

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

A
Amneal Pharmaceuticals, LLC — Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-2

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

A
Amneal Pharmaceuticals, LLC — chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213,

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

A
Aesculap AG — AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

B
Boston Scientific Corporation — Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

A
Aesculap AG — AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

C
CORNEAT VISION, LTD. — CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

C
CORNEAT VISION, LTD. — EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

M
Maquet Cardiovascular, LLC — Heartstring III Proximal Seal System. Intravascular anastomosis occluder.

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

S
Stanley Pearlman Enterprises, Inc. — NAFCO, WHITING FILLET SKIN-ON BONELESS IQF, 2 lb., Cases are corrugate. The product is individually frozen and packed in food contact retail bag. 15 bags per case.

Recall initiated due to the wrong best by date (1-11-2025) being printed on the retail bag which would imply that these are expired but in truth they are good until 1-11-2027.

E
M
Maquet Cardiovascular, LLC — Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

E
M
Maquet Cardiovascular, LLC — Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

B
Beckman Coulter Inc. — UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

C
CHANGE HEALTHCARE CANADA COMPANY — Change Healthcare Radiology Solutions software version 14.2.2

Due to software issue, radiology reports may not be fully displayed when viewing.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

B
Beckman Coulter Inc. — UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Sl

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity F

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

B
Beckman Coulter Inc. — UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

B
Beckman Coulter Inc. — UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model N

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

P
Philips North America Llc — Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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