Browse Device Recalls

1,361 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,361 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,361 FDA device recalls in NY.

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Date	Product	Reason	Class	Firm
Aug 29, 2016	Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier ...	Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 29, 2016	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H...	Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 29, 2016	BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit...	Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Aug 24, 2016	SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number ...	Siemens received multiple customer complaints indicating an increase in false positive and indete...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 24, 2016	SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number ...	Siemens received multiple customer complaints indicating an increase in false positive and indete...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 11, 2016	VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides ...	Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o...	Class II	Ortho-Clinical Diagnostics
Aug 11, 2016	VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides ...	Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o...	Class II	Ortho-Clinical Diagnostics
Aug 11, 2016	VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides ...	Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o...	Class II	Ortho-Clinical Diagnostics
Aug 11, 2016	VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides...	Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o...	Class II	Ortho-Clinical Diagnostics
Jul 20, 2016	ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA...	Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System So...	Class II	Siemens Healthcare Diagnostics, Inc.
Jul 11, 2016	Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: ...	Possible dull knife edge	Class II	Bausch & Lomb Inc Irb
Jul 11, 2016	OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 63...	After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away...	Class II	Ivoclar Vivadent, Inc.
Jul 11, 2016	Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to...	Possible dull knife edge	Class II	Bausch & Lomb Inc Irb
Jul 11, 2016	Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 ...	The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator ...	Class III	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Jul 8, 2016	Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE...	A software issue related to the generic volume measurement functionality could result in the volu...	Class II	Carestream Health Inc
Jul 1, 2016	The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressur...	Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.	Class III	Circulatory Technology Inc
Jul 1, 2016	The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB...	The seal between the balloon and the housing may leak.	Class II	Circulatory Technology Inc
Jun 27, 2016	CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual ...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Ca...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 27, 2016	CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single So...	The packaging seal may contain a crease. The crease may result in an open channel. These channel...	Class II	ConMed Corporation
Jun 22, 2016	VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For ...	The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the a...	Class III	Ortho-Clinical Diagnostics
Jun 8, 2016	Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-...	There is a potential for stylet stiffening that is not accurately represented on the labeling. Th...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Jun 8, 2016	Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-...	There is a potential for stylet stiffening that is not accurately represented on the labeling. Th...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Jun 8, 2016	AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 1...	The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling ...	Class II	Amd-Ritmed, Inc.
May 27, 2016	Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring de...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring de...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For color...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For colori...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For colori...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For colo...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For colorin...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring d...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For c...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 27, 2016	Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring ...	The primary packaging of these products may show leaks in individual cases. As a consequence, the...	Class II	Ivoclar Vivadent, Inc.
May 26, 2016	ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 108197...	Eight (8) issues were identified which may affect the results generated by the system software ve...	Class II	Siemens Healthcare Diagnostics, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.