Browse Device Recalls

2,036 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,036 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 2,036 FDA device recalls in NJ.

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Date	Product	Reason	Class	Firm
Apr 29, 2022	INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovin...	Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm,...	Class II	Maquet Cardiovascular, LLC
Apr 13, 2022	Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-cham...	Verification of installation not documented or may be incomplete, could result in harm to the use...	Class II	Getinge Usa Sales Inc
Apr 13, 2022	Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washe...	Verification of installation not documented or may be incomplete, could result in harm to the use...	Class II	Getinge Usa Sales Inc
Apr 1, 2022	Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 91...	Inadequate documentation verifying whether device installation has been executed in accordance wi...	Class II	Getinge Usa Sales Inc
Apr 1, 2022	Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02	Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CL...	Class I	CELLTRION USA INC
Mar 30, 2022	Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Tri...	Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial C...	Class II	Howmedica Osteonics Corp.
Mar 25, 2022	VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 184...	Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun...	Class II	Ortho-Clinical Diagnostics, Inc
Mar 25, 2022	VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922	Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun...	Class II	Ortho-Clinical Diagnostics, Inc
Mar 25, 2022	VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198	Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun...	Class II	Ortho-Clinical Diagnostics, Inc
Mar 24, 2022	STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product cod...	Affected product lots may contain the incorrect needle type/size and suture length due to compone...	Class II	Ethicon, Inc.
Feb 28, 2022	Integra Universal Flexible Arm part number REF 1362275	Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at ...	Class II	Integra LifeSciences Corp.
Feb 25, 2022	Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02	Kits were labeled with incorrect expiration dates.	Class II	CELLTRION USA INC
Feb 18, 2022	Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood ...	Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of th...	Class II	Maquet Medical Systems USA
Feb 9, 2022	Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF ...	Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms ma...	Class II	Maquet Cardiovascular, LLC
Jan 21, 2022	Codman Cranial Access Kits- indicated when a craniotomy is required for place...	Incorrect extended expiration dates identified on the outer box label only, if product is used pa...	Class II	Integra LifeSciences Corp.
Jan 21, 2022	Codman Cranial Access Kits- indicated when a craniotomy is required for place...	Incorrect extended expiration dates identified on the outer box label only, if product is used pa...	Class II	Integra LifeSciences Corp.
Jan 14, 2022	HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6...	Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 ...	Class II	Maquet Cardiovascular, LLC
Jan 14, 2022	Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032	Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i...	Class II	Howmedica Osteonics Corp.
Jan 14, 2022	Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232	Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i...	Class II	Howmedica Osteonics Corp.
Jan 6, 2022	BD Vacutainer Luer Lok Access Device - intended as a sterile, single use devi...	May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cel...	Class III	Becton Dickinson & Company
Dec 30, 2021	Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044	There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E...	Class II	Howmedica Osteonics Corp.
Dec 30, 2021	Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440	There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E...	Class II	Howmedica Osteonics Corp.
Dec 28, 2021	Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02	The affected lot was placed under quarantine in September 2021 due to complaints of alleged false...	Class I	CELLTRION USA INC
Dec 21, 2021	Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110	There is a potential for the outer Tyvek lid to de-bond from the sealed package.	Class II	Howmedica Osteonics Corp.
Dec 21, 2021	C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, hepar...	ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are pos...	Class II	DRG International, Inc.
Dec 21, 2021	32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032	There is a potential for the outer Tyvek lid to de-bond from the sealed package.	Class II	Howmedica Osteonics Corp.
Dec 13, 2021	RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for ...	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o...	Class II	Collagen Matrix, Inc.
Dec 13, 2021	DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0...	Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk o...	Class II	Collagen Matrix, Inc.
Dec 9, 2021	Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the fo...	A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) h...	Class I	Getinge Usa Sales Inc
Dec 3, 2021	ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing a...	lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incor...	Class II	Konica Minolta Healthcare Americas, Inc.
Dec 2, 2021	Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02	Returned test kits were erroneously shipped to customers. The kits are intended for Research Use ...	Class I	CELLTRION USA INC
Dec 1, 2021	Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis...	The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ...	Class II	CELLTRION USA INC
Dec 1, 2021	Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890	There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated...	Class II	Maquet Cardiovascular, LLC
Nov 24, 2021	Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage...	Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel ...	Class II	Howmedica Osteonics Corp.
Nov 16, 2021	cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material...	Roche has identified a small number of cobas Liat analyzer units that have consistently high nois...	Class II	Roche Molecular Systems, Inc.
Nov 15, 2021	Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0...	Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic...	Class I	Datascope Corp.
Nov 15, 2021	Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0...	Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the devic...	Class I	Datascope Corp.
Oct 18, 2021	Total Thyroxine (T4) ELISA; REF EIA-1781	Firm has identified two lots of product that do not meet product shelf life, resulting in failed ...	Class II	DRG International, Inc.
Oct 15, 2021	28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028	XXX	Class II	Howmedica Osteonics Corp.
Oct 15, 2021	28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122	There is a potential for the outer white Tyvek lid to debond from the sealed package.	Class II	Howmedica Osteonics Corp.
Sep 27, 2021	BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used...	Holes in product packaging impacts package integrity and may compromise sterility.	Class II	Becton Dickinson & Company
Sep 21, 2021	Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Card...	A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum run...	Class I	Datascope Corp.
Sep 10, 2021	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (I...	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Co...	Class II	Ortho Clinical Diagnostics Inc
Sep 8, 2021	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7...	The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in...	Class II	Datascope Corp.
Sep 8, 2021	Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-7...	The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b...	Class II	Datascope Corp.
Sep 8, 2021	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3...	The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in...	Class II	Datascope Corp.
Sep 8, 2021	Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-3...	The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one b...	Class II	Datascope Corp.
Sep 3, 2021	cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog N...	False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas...	Class II	Roche Molecular Systems, Inc.
Aug 27, 2021	Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft versi...	When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or Ver...	Class II	PTW NORTH AMERICA CORPORATION
Aug 4, 2021	cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catal...	Customers have reported an increased number of false positive SARS-CoV-2 results.	Class II	Roche Molecular Systems, 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.