Recall

All recalls7,814 total

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Medline Industries, LP — Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,C

Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

M
Medline Industries, LP — Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X

Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

U
Ultradent Products, Inc. — Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.

S
SUN PHARMACEUTICAL INDUSTRIES INC — Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A.

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

B
Becton Dickinson & Company — 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.

During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

L
Lutronic Corporation — CLARITY II Laser System; Model No. 1110200210.

Reports of devices sparking/popping and potentially burning patients.

A
Abiomed, Inc. — Impella RP with SmartAssist. Product Code: 0046-0035.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

A
Abiomed, Inc. — Impella RP Flex with SmartAssist. Product Code: 1000323.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

A
Abiomed, Inc. — Impella RP. Product Code: 0046-0011.

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

G
Gerber Products Company dba Nestle Infant Nutrition — Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 0150009

Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

P
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

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