Recalls affecting New York
Notices that name New York in their distribution area, plus every nationwide recall — nationwide recalls reach New York too.
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Class II · last month
embecta Medical II LLC EWO_02512 For Investigational Use Only Nano Pro Un-Cannulated recall: Retrospectively reported: Pen needles labeled 'For Investigational Use Only'
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
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Class II · last month
Howmedica Osteonics Corp. Bearing AND Axle Bushing Assy STD Elbow C-M113-1-301 KRH recall: Affected devices were manufactured with Ultra High Molecular Weight
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the…
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Class I · last month
Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter recall: A software synchronization/timing issue in the barcode scanning and patient
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain…
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Class II · last month
GE Healthcare Core Services Hub V8, a set of backend services including Cross recall: Under certain conditions historical imaging data migrated from a legacy
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this…
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Class I · last month
AVID Medical, Inc. Halyard IV Start KIT Non-Sterile REF: Kriv26-02 recall: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
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Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
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Class II · last month
Howmedica Osteonics Corp. Scorpio + Mobile Bearing PCS 78-5-0910 System ONE Bipolar recall: Affected devices were manufactured with Ultra High Molecular Weight
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the…
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Class I · last month
Bard Access Systems, Inc. Power-Trialysis Short-Term Straight Dialysis Catheter recall: this is a downstream recall of class I recall RES 98777
this is a downstream recall of class I recall RES 98777
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Class I · last month
Medline Convenience Kits: 1) ACC010308A recall: The kits contain certain lots of sterile applicators which may contain fungal
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions…
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Class II · last month
Howmedica Osteonics Corp. Duracon XL Angled TIB INS 11/14MM C-M064-1-300 recall: Affected devices were manufactured with Ultra High Molecular Weight
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the…
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Class II · last month
Howmedica Osteonics Corp. ALL Poly Constrained Insert 54MM 69-2854 NRG Knee CR recall: Affected devices were manufactured with Ultra High Molecular Weight
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the…
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Class II · last month
Stryker Sustainability Solutions REF:B12LT Ethicon Endo-Surgery recall: Reusable access port system may crack or seperate during use
Reusable access port system may crack or seperate during use.
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Class II · last month
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/ recall: Extra small (ES) and Extra-large (XL) infant sleep sacks have
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
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Class II · last month
Medline Industries, LP Convenience kits Anesthesia Pain PK League Dynj67925A recall: Kits may exhibit open seals in sterile pouch packaging. Open seal
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to…
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Class II · last month
Ptw Freiburg Brand Name: Veriqa recall: When a bolus is included in a treatment plan and sent for secondary dose
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly…
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Class II · last month
NOxBOXi Nitric Oxide Delivery System recall: Potential for oxygen tubing leaks due to failure of the tubing or tubing
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
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Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
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Class II · last month
Medline Industries, LP Convenience kits Myringotomy Pack-Lf Dynj59097A recall: Kits may exhibit open seals in sterile pouch packaging. Open seal
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to…
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Class II · last month
Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit , Guidewire 150 cm recall: The packaging may not consistently maintain sterile barrier integrity
The packaging may not consistently maintain sterile barrier integrity.
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Class I · last month
Abiomed, Inc. Impella Optical Controller, Automated Impella Controller recall: The potential for purge cassette recognition issues due to the failure
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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Class II · last month
Boston Scientific Corporation StoneSmart Connect Console Contents recall: A subset of power adapters used with the connect console may exhibit
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result…
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Class I · last month
Medline Convenience Kits: 1) DYNDB3086D recall: The kits contain certain lots of sterile applicators which may contain fungal
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions…
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Class I · last month
Medline Convenience Kits: 1) Open Heart Adult recall: The kits contain certain lots of sterile applicators which may contain fungal
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions…
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Class II · last month
GE Healthcare Centricity Enterprise Archive V2, V3, and V4 recall: Under certain conditions historical imaging data migrated from a legacy
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this…