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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DateProductReasonClassFirm
Aug 3, 2017 Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Aug 3, 2017 Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 Complaints were filed claiming the material consistency was too soft and too sticky in comparison... Class III Ivoclar Vivadent, Inc.
Jul 7, 2017 Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery... The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective ... Class II Ondamed Inc
Jun 29, 2017 Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Si... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: S... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siem... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K201... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Sieme... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/104643... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative dete... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: ... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 29, 2017 ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended t... Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid ... Class II Siemens Healthcare Diagnostics, Inc.
Jun 27, 2017 Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspi... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # ... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 27, 2017 Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Us... BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign ma... Class II Robert Busse & Co. Inc. d.b.a. Busse Hospital D...
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets ... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 19, 2017 STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administr... Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. Class II ConMed Corporation
Jun 12, 2017 VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Or... The firm identified the potential for biased results to be generated when processing VITROS PHYT ... Class II Ortho-Clinical Diagnostics
Jun 5, 2017 Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H78... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) ... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (U... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model ... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 1, 2017 BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usa... Intact carton revealed presence of shredded burn sheets Class II Dukal Corp.
May 25, 2017 DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all othe... Carestream found a single unit where four screws in the assembly were not applied in the manufact... Class II Carestream Health Inc
Apr 26, 2017 enGen Track System with TCAutomation Software Version 4.2 A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results d... Class II Ortho-Clinical Diagnostics
Apr 17, 2017 Nonabsorbable suture anchor system intended to reattach soft tissue to bone i... Manufactured with the incorrect anchor outer body Class II ConMed Corporation
Apr 3, 2017 Solus Flexible wire-reinforced laryngeal mask airways under the following siz... A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff i... Class II Intersurgical Inc
Mar 13, 2017 Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-... SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under t... Class II Valeant Pharmacueticals International
Mar 8, 2017 enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software ... Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, s... Class II Ortho-Clinical Diagnostics
Mar 3, 2017 LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT C... The complaints database was reviewed and there have been an atypical volume of dull blades compla... Class II Bausch & Lomb Inc Irb
Mar 3, 2017 LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E757... The complaints database was reviewed and there have been an atypical volume of dull blades compla... Class II Bausch & Lomb Inc Irb
Mar 3, 2017 LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PROD... The complaints database was reviewed and there have been an atypical volume of dull blades compla... Class II Bausch & Lomb Inc Irb
Mar 3, 2017 LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE... The complaints database was reviewed and there have been an atypical volume of dull blades compla... Class II Bausch & Lomb Inc Irb
Mar 3, 2017 LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE ... The complaints database was reviewed and there have been an atypical volume of dull blades compla... Class II Bausch & Lomb Inc Irb

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.