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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 821–840 of 1,000 recalls

Class IITerminated

Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.

Straumann USA LLC

Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury

May 27, 2021 · DeviceView details →

Class IITerminated

Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798

Cell Marque Corporation

Product distributed for use as an In-vitro Diagnostics without FDA clearance

May 27, 2021 · DeviceView details →

Class IITerminated

Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507

Edwards Lifesciences, LLC

There is a potential that the pressure tubing may detach from the blood sampling system

May 26, 2021 · DeviceView details →

Class IITerminated

Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II Programmable 40mLPump 00810335020242

Flowonix Medical Inc

Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection

May 26, 2021 · DeviceView details →

Class IITerminated

Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count; 2. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 240 count; 3. BEAUTY 360 Patterned Basic Cotton Rounds - multipurpose 80 count; 4. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 80 count; 5. Medline non-sterile Cotton Rounds 80 count; 6. Simply Soft Cotton Rounds - Trial Size 30 counts; 7. Simply Soft Premium Cotton Rounds 80 Count; and 8. W Textured Cotton Rounds 240 Count. For application of cleansers and astringents, and the removal of makeup and nail polish; for cleaning superficial cuts and scrapes and applying medication to the skin.

Medline Industries Inc

Potential for mold contamination (Aspergillus vadensis)

May 25, 2021 · DeviceView details →

Class IITerminated

Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →

Class IITerminated

Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →

Class IITerminated

Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →

Class IITerminated

Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →

Class IITerminated

Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →

Class IITerminated

SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria.

Sunstar Americas, Inc.

Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.

May 21, 2021 · DeviceView details →

Class IITerminated

Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →

Class IITerminated

Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →

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