Browse Device Recalls
2,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,057 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 2,057 FDA device recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 22, 2022 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A precon... | The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the ste... | Class II | Maquet Medical Systems USA |
| Jul 21, 2022 | Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for ... | Device does not meet regulatory requirements of stability while stationary, which requires mechan... | Class II | Getinge Usa Sales Inc |
| Jul 20, 2022 | Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694... | Ventilators may generate a combination of alarms which may result in loss of communication, techn... | Class I | Getinge Usa Sales Inc |
| Jul 18, 2022 | BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Dr... | Incorrect expiration date listed on the product labels. The expiration date listed on the product... | Class II | Becton Dickinson & Company |
| Jun 23, 2022 | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) ... | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible ... | Class II | Mallinckrodt, LLC. |
| Jun 22, 2022 | CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure mon... | Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) ... | Class I | Integra LifeSciences Corp. |
| Jun 21, 2022 | etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. | Device was marketed without FDA 510(k) clearance or a PMA. | Class II | Touch US Llc |
| May 9, 2022 | BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.3836... | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 9, 2022 | BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS) | May have the potential for leakage at the housing component of the stopcock, may result in delay ... | Class II | Becton Dickinson & Company |
| May 6, 2022 | VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600... | Paint particles may detach and fall in the operating field. In the worst case scenario, infection... | Class II | Getinge Usa Sales Inc |
| May 2, 2022 | Flow-e Anesthesia System : Intended for use in administering anesthesia while... | Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... | Class I | Getinge Usa Sales Inc |
| May 2, 2022 | Flow-c Anesthesia System : intended for use in administering anesthesia whil... | Potential for crack to form on the on/off switch of the suction unit, which may result in an unre... | Class I | Getinge Usa Sales Inc |
| 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 |
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.