Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 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 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 30, 2022 | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-... | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... | Class II | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Aug 30, 2022 | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-... | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... | Class II | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Aug 22, 2022 | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ... | Weak skin adhesion. | Class II | SenTec AG |
| Aug 19, 2022 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... | Class III | Canadian Hospital Specialties |
| Aug 12, 2022 | Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mob... | Due to un-commanded movement of mobile x-ray unit. | Class II | SEDECAL SA |
| Aug 9, 2022 | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Ca... | Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, o... | Class I | Jiangsu Well Biotech Co.,Ltd. |
| Aug 9, 2022 | Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B | Products were distributed in the United States without FDA authorization or clearance. | Class I | DEWEI MEDICAL EQUIPMENT CO LTD |
| Aug 1, 2022 | The Randox Serology I Positive Control contains the following analytes in hum... | ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckm... | Class II | Randox Laboratories Ltd. |
| Jul 27, 2022 | Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Nu... | installation issues | Class II | BARCO NV |
| Jul 27, 2022 | ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP,... | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. | Class II | GELITA MEDICAL GMBH |
| Jul 21, 2022 | Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 10028... | The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an ... | Class II | Unomedical A/S |
| Jul 11, 2022 | SafeControl handset (a component of the Sentida bed which moves and positions... | When the handset is disconnected from the power mains, and mains operation is restored, the hands... | Class II | WISSNER-BOSSERHOFF GMBH |
| Jul 4, 2022 | Medicina Reusable Oral syringe 1ml Code: OTH01 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Reusable Oral syringe 2.5ml Code: OTH25 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Oral Tip Syringe 1ml Code: OT01 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Reusable Oral syringe 5ml Code: OTH05 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Oral Tip Syringe 2.5ml Code: OT25 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Oral Tip Syringe 0.5ml Code: OT005 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jun 22, 2022 | Randox Cholesterol- For the quantitative in vitro determination of Cholester... | Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when cali... | Class II | Randox Laboratories Ltd. |
| Jun 9, 2022 | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... | Class III | Randox Laboratories Ltd. |
| Jun 9, 2022 | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... | Class III | Randox Laboratories Ltd. |
| Jun 2, 2022 | YelloPort Elite Universal Seal. For use in laparoscopic procedures. | There is the potential that YelloPort Elite Universal Seals packaging may contain small holes whi... | Class II | Surgical Innovations Ltd |
| Jun 1, 2022 | RayStation 9B SP1. For radiation treatment planning. | An issue with propagation of treatment course information from RayStation with RayTreat to RayCar... | Class II | RAYSEARCH LABORATORIES AB |
| May 30, 2022 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550 | The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 19, 2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... | Class II | Chromsystems Instruments & Chemicals GmbH |
| May 19, 2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... | Class II | Chromsystems Instruments & Chemicals GmbH |
| May 18, 2022 | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 | There is a potential for sporadic incidents of positive and negative biases for analyzer systems ... | Class II | Radiometer Medical ApS |
| May 13, 2022 | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MIC... | The outer package is mislabeled and the package contains a different IOL strength. | Class II | Rayner Intraocular Lenses Ltd |
| Apr 27, 2022 | X80 RADiant Photoelectric Therapy System | There is a potential compatibility issue with the systems and replacement treatment applicators. | Class II | Xstrahl Limited |
| Apr 20, 2022 | Proteus235- Proton Therapy System: to produce and deliver a proton beam for ... | First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning ... | Class II | Ion Beam Applications S.A. |
| Apr 8, 2022 | XVIVO Organ Chamber REF 19020 | The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ens... | Class II | XVIVO PERFUSION AB |
| Apr 8, 2022 | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU elect... | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. | Class II | Radiometer Medical ApS |
| Apr 7, 2022 | NanoSight NS300 | Product found to not comply to Class 1 Laser safety requirement. | Class II | MALVERN PANALYTICAL LTD |
| Mar 25, 2022 | CK MB Calibrator, Catalogue Number CK2393 | Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value... | Class III | Randox Laboratories Ltd. |
| Mar 21, 2022 | ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0... | Software issue for treatment plan and image management application may result in mismatch values ... | Class II | Varian Medical Systems Imaging Laboratory GmbH |
| Mar 8, 2022 | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 | Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of h... | Class II | SIMPLIVIA HEALTHCARE LTD. |
| Feb 28, 2022 | NanoSight LM10 fitted with LM14 module. A laboratory instrument for determin... | Product found to not comply to Class 1 Laser safety requirement. | Class II | MALVERN PANALYTICAL LTD |
| Feb 28, 2022 | NanoSight LM10 fitted with LM12 module. A laboratory instrument for determin... | Product found to not comply to Class 1 Laser safety requirement. | Class II | MALVERN PANALYTICAL LTD |
| Feb 25, 2022 | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Mon... | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | Class II | Brainlab AG |
| Feb 15, 2022 | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for... | When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range... | Class II | Ion Beam Applications S.A. |
| Feb 14, 2022 | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 | Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ... | Class III | Cytocell Ltd. |
| Feb 4, 2022 | TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq... | May show unexpected locus specific signals in addition to those at 14q32. | Class III | Cytocell Ltd. |
| Jan 31, 2022 | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rap... | Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved,... | Class I | SD Biosensor, Inc. |
| Jan 20, 2022 | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; Yell... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 20, 2022 | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in lapar... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 18, 2022 | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | Incorrect marketing label (25 mm) was applied to product size 20 mm. | Class II | Merete Medical GmbH |
| Jan 18, 2022 | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c... | individual components have been labelled with incorrect colours. The red and green colours are op... | Class II | Cytocell Ltd. |
| Jan 11, 2022 | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/... | Retinal analysis system software has some features, based on artificial intelligence, that potent... | Class II | Diagnos 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.