Browse Device Recalls
2,049 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,049 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 2,049 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 20, 2023 | Zenition 70. The device is to be used in health care facilities both inside a... | Philips has become aware of the potential for unintended radiation exposure with Zenition 70 syst... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | NOxBOXi Nitric Oxide Delivery System | Replacement of the internal Sample Pump due to high failure rates. | Class II | NOXBOX LTD |
| Jul 19, 2023 | MultiDiagnost-Eleva | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Azurion | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Allura Xper series | A foot switch pedal may get stuck in the active position when the user releases the pedal, resul... | Class II | Philips Medical Systems Nederland B.V. |
| Jul 19, 2023 | Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product us... | As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Lab... | Class II | Randox Laboratories Ltd. |
| Jul 17, 2023 | RayCare software, include version number 5A, 5B, 6A, including service packs-... | An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warn... | Class II | RAYSEARCH LABORATORIES AB |
| Jul 17, 2023 | Aquilex Fluid Control System-Intended to provide fluid distension of the uter... | The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflo... | Class II | WOM World Of Medicine AG |
| Jul 14, 2023 | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile | Wrong product coloring. The paddle clips should be blank, but they are colored blue. | Class II | Peter Lazic Gmbh |
| Jul 14, 2023 | MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Ins... | Product is labeled with incorrect offset. | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 14, 2023 | L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile | Wrong product coloring. The paddle clips should be blank, but they are colored blue. | Class II | Peter Lazic Gmbh |
| Jul 13, 2023 | Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and... | May have a battery life lasting less than the full 48 hours, requiring the device to be charged m... | Class II | EMPATICA SRL |
| Jul 12, 2023 | IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, ... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, ... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, ... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, ... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, ... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d)... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 12, 2023 | IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d... | There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... | Class II | Medicrea International |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for pat... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 3, 2023 | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for p... | Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jun 30, 2023 | Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interve... | Loss of availability of the wireless foot switch during procedures. | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 23, 2023 | UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿... | There is an improperly performed weld between the cone of the sheath lock and tube of the obturat... | Class II | Scholly Fiberoptic Gmbh |
| Jun 22, 2023 | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... | Class II | Scican Ltd. |
| Jun 22, 2023 | Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access | Three lots of product may be labeled with an incorrect expiration day | Class II | Creganna Medical Devices |
| Jun 22, 2023 | STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... | The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... | Class II | Scican Ltd. |
| Jun 21, 2023 | Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in... | (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which sh... | Class II | Randox Laboratories Ltd. |
| Jun 19, 2023 | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to gui... | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request | Class II | Materialise N.V. |
| Jun 13, 2023 | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (... | Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bi... | Class II | Randox Laboratories Ltd. |
| Jun 12, 2023 | Allura Xper FD10 and FD20. X-ray Imaging System. | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear i... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 12, 2023 | Azurion 7 M20. X-ray Image guided Therapy System. | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear i... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 9, 2023 | REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, S... | Sterility of Ultrasound gel can not be guaranteed. | Class II | Turkuaz Saglik Hizmetleri Medikal Temizlik Kim.... |
| Jun 5, 2023 | VITROS Immunodiagnostic Products Troponin I ES Calibrators | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Jun 5, 2023 | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Jun 2, 2023 | Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 1... | A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... | Class II | Beckman Coulter Biomedical GmbH |
| Jun 2, 2023 | Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240... | A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... | Class II | Beckman Coulter Biomedical GmbH |
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.