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
May 4, 2020	BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated fo...	Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled...	Class II	Angiodynamics, Inc.
May 4, 2020	BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are ...	Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled...	Class II	Angiodynamics, Inc.
May 4, 2020	BioFlo Midline Convenience Kits - Product Usage: These introducers are used f...	Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled...	Class II	Angiodynamics, Inc.
Apr 24, 2020	AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Ele...	Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes t...	Class II	Angiodynamics, Inc.
Apr 1, 2020	VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8...	The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas...	Class II	Ortho-Clinical Diagnostics
Apr 1, 2020	VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 80011...	The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas...	Class II	Ortho-Clinical Diagnostics
Mar 10, 2020	VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468	The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.	Class III	Ortho Clinical Diagnostics
Feb 27, 2020	Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software vers...	Editing an assay Test Definition and switching to another assay s Test Definition screen without ...	Class II	Siemens Healthcare Diagnostics, Inc.
Feb 14, 2020	Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 1109...	The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibratio...	Class II	Siemens Healthcare Diagnostics, Inc.
Feb 5, 2020	IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - ...	Due to high discordant Estradiol results which.potentially affects all patient populations, A fal...	Class II	Siemens Healthcare Diagnostics, Inc.
Feb 5, 2020	IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L...	Due to high discordant Estradiol results which.potentially affects all patient populations, A fal...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 29, 2020	Class IV New Era medical laser device	The firm failed to comply with the applicable standards regarding Electronic Product Radiation Co...	Class II	Inova Lasers LLC
Jan 13, 2020	Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydro...	Incorrect power of lenses than the expected	Class II	CooperVision Inc.
Jan 13, 2020	Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydro...	Incorrect power of lenses than the expected	Class II	CooperVision Inc.
Jan 12, 2020	Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143	Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the ...	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020	Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diag...	Carestream Health has discovered a potential safety problem that can lead to unintended movement ...	Class II	Carestream Health, Inc.
Jan 6, 2020	Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software...	A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.	Class II	Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020	Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software...	A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 31, 2019	Koios DS Breast <series 1.0>. The device is a software application which assi...	Affected software product versions were found during internal audit to have been marketed for sal...	Class II	Koios Medical, Inc.
Dec 20, 2019	ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. ...	Firm has received customer complaints regarding failed calibrations and increased imprecision of ...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019	ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869	There is a potential for falsely depressed creatinine results for patients on phenindione therapy...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019	Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520	There is a potential for falsely depressed creatinine results for patients on phenindione therapy...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019	Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533	There is a potential for falsely depressed creatinine results for patients on phenindione therapy...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019	Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444	There is a potential for falsely depressed creatinine results for patients on phenindione therapy...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019	MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Nov 19, 2019	MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated ...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Nov 19, 2019	MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD s...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Nov 19, 2019	OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Us...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Nov 19, 2019	Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product ...	Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019	ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calib...	Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-D...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019	OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Numbe...	May result in readings outside of the expected accuracy range.	Class II	Angiodynamics, Inc.
Oct 11, 2019	Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions...	On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Mult...	Class II	Siemens Healthcare Diagnostics, Inc.
Oct 2, 2019	Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)	When the user tilts the transmitted light arm of the microscope to the end of its axis range, las...	Class II	Zeiss, Carl Inc
Oct 2, 2019	Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 ...	The devices are not labelled correctly. End users impacted by this issue may experience a proced...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 23, 2019	Atellica CH 930 Analyzer	Potential for calibration error resulting in QC failures after the calibration run with QC and pa...	Class II	Siemens Healthcare Diagnostics, Inc.
Sep 18, 2019	BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 ...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 ...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 18, 2019	BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-02...	Snap lock connectors provided within implantable port kits may not meet dimensional specification...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Sep 10, 2019	VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Uri...	Users may experience intermittent slide dispense issues with some cartridges due to the anti-back...	Class II	Ortho-Clinical Diagnostics
Sep 10, 2019	VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which c...	Users may experience intermittent slide dispense issues with some cartridges due to the anti-back...	Class II	Ortho-Clinical Diagnostics
Sep 10, 2019	VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT sup...	Users may experience intermittent slide dispense issues with some cartridges due to the anti-back...	Class II	Ortho-Clinical Diagnostics
Aug 20, 2019	20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product...	Mislabeled needle lengths	Class II	Repro-Med Systems, Inc.
Aug 15, 2019	Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Materia...	Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 15, 2019	Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material...	Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM...	Class II	Siemens Healthcare Diagnostics, Inc.
Aug 7, 2019	Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P...	The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos...	Class II	Intersurgical Inc
Aug 7, 2019	Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996...	The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos...	Class II	Intersurgical Inc
Aug 7, 2019	Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898...	The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos...	Class II	Intersurgical Inc
Aug 7, 2019	Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy P...	The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could pos...	Class II	Intersurgical 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.