Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 25, 2023 | Multichem P, Part Code 08P90-10 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Aug 23, 2023 | LFS Flat screen arm system with surgical lamp for Models Aurora series, Auror... | The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Aug 23, 2023 | LFS Flat screen support arm systems without surgical lamp for models Aurora s... | The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... | Class II | DKK Dai-Ichi Shomei Co., Ltd. |
| Aug 22, 2023 | therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Roto... | Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_... | Class II | Qiagen GmbH |
| Aug 18, 2023 | OPMI LUMERA 300, REF 6137 | Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, whic... | Class II | Carl Zeiss Suzhou Co., Ltd. |
| Aug 17, 2023 | SOZO Bilateral Arm L-Dex Software | Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect ea... | Class II | Impedimed Limited |
| Aug 17, 2023 | exoplan version 3.1 Rijeka Software -A medical software, intended to support ... | A software library filtering error has been discovered which occurs when users are using the Step... | Class II | Exocad GmbH |
| Aug 10, 2023 | Functional MR V1.0 | When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting mu... | Class II | OLEA MEDICAL |
| Aug 8, 2023 | Oculus Pentacam AXL Wave, Ref 70020, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 8, 2023 | Oculus Myopia Master , Ref 68100, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 8, 2023 | Oculus Pentacam AXL , Ref 70100, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 3, 2023 | 3T Heater Cooler System, REF: 16-02-85 | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance sch... | Class II | LivaNova Deutschland GmbH |
| Jul 27, 2023 | Henke-Ject-2 part luer sterile single use syringes - used for intravenous, in... | Sterile barrier might be damaged compromising the sterility of the device. | Class II | Wolf, Henke Sass, Gmbh |
| Jul 27, 2023 | Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466,... | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exp... | Class II | Aomori Olympus Co., Ltd. |
| Jul 27, 2023 | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be att... | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exp... | Class II | Aomori Olympus Co., Ltd. |
| Jul 26, 2023 | Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral ... | A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| 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) |
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.