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FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

28,065medical device recall records

2,353FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 949

28,065 detailed records are currently available in this category.

Medical DeviceJun 14, 2017

Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central recall — FDA Z-2266-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

ConvaTec Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 recall — FDA Z-2242-2017

Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E

Class IIFDA: TerminatedConvaTec, Inc.

Medical DeviceJun 14, 2017

Arrow International QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow recall — FDA Z-2301-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Arrow International Femoral Arterial Line Catheterization Kit The Arrow Arterial recall — FDA Z-2295-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Arrow International Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath recall — FDA Z-2304-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Arrow International Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous recall — FDA Z-2274-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr recall — FDA Z-2282-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

ConvaTec Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing recall — FDA Z-2234-2017

Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM

Class IIFDA: TerminatedConvaTec, Inc.

Medical DeviceJun 14, 2017

Cook Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by recall — FDA Z-2312-2017

COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and…

Class IIFDA: TerminatedCook Inc.

Medical DeviceJun 14, 2017

Arrow International Arrow(R) Access Kit for use with 4 Fr recall — FDA Z-2288-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Beekley Medical 0-SPOT Mammography Skin Markers REF 652 recall — FDA Z-2309-2017

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

Class IIIFDA: TerminatedBeekley Corporation

Medical DeviceJun 14, 2017

Arrow International Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with recall — FDA Z-2276-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

ConvaTec Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code recall — FDA Z-2228-2017

Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an…

Class IIFDA: TerminatedConvaTec, Inc.

Medical DeviceJun 14, 2017

ConvaTec Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 recall — FDA Z-2240-2017

Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E

Class IIFDA: TerminatedConvaTec, Inc.

Medical DeviceJun 14, 2017

Arrow International Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with recall — FDA Z-2271-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Argon Medical Devices Clear Flashback Needle 7cm x 18G AMC/4 recall — FDA Z-2252-2017

Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void…

Class IIFDA: TerminatedArgon Medical Devices, Inc.

Medical DeviceJun 14, 2017

Arrow International Arterial Catheterization Kit The Arrow Arterial Catheterization device recall — FDA Z-2300-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

ConvaTec Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product recall — FDA Z-2238-2017

Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002,…

Class IIFDA: TerminatedConvaTec, Inc.

Medical DeviceJun 14, 2017

Circadiance SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE recall — FDA Z-2250-2017

Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to…

Class IIFDA: TerminatedCircadiance LLC

Medical DeviceJun 14, 2017

ConvaTec Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E recall — FDA Z-2244-2017

Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA

Class IIFDA: TerminatedConvaTec, Inc.

Medical DeviceJun 14, 2017

ConvaTec Pediatric, High Conc recall — FDA Z-2245-2017

Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E

Class IIFDA: TerminatedConvaTec, Inc.

Medical DeviceJun 14, 2017

Arrow International Arrow(R) VPS(R) Access Kit for use with 4 Fr recall — FDA Z-2281-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Arrow International Femoral Arterial Line Catheterization Kit The Arrow Arterial recall — FDA Z-2294-2017

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceJun 14, 2017

Cook LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in recall — FDA Z-2315-2017

COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and…

Class IIFDA: TerminatedCook Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.