Browse Device Recalls
40,358 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 40,358 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 40,358 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2026 | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Int... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 21, 2026 | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 7... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 7... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253; | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 78... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | MR 5300 Model Number (REF): 1. 782110, 2. 782152; | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3.... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 21, 2026 | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), ... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 21, 2026 | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 78134... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 20, 2026 | Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalo... | Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or ab... | Class II | Medtronic MiniMed, Inc. |
| Aug 20, 2026 | PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. ... | Potential for monomer liquid leakage. | Class II | Heraeus Medical GmbH (Dental Division) |
| Aug 20, 2026 | Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; M... | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... | Class II | Alere San Diego, Inc. |
| Aug 20, 2026 | PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 508128... | Potential for monomer liquid leakage. | Class II | Heraeus Medical GmbH (Dental Division) |
| Aug 20, 2026 | PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635.... | Potential for monomer liquid leakage. | Class II | Heraeus Medical GmbH (Dental Division) |
| Aug 20, 2026 | McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG C... | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... | Class II | Alere San Diego, Inc. |
| Aug 20, 2026 | PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081... | Potential for monomer liquid leakage. | Class II | Heraeus Medical GmbH (Dental Division) |
| Aug 20, 2026 | Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry S... | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... | Class II | Alere San Diego, Inc. |
| Aug 20, 2026 | EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number... | Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration... | Class II | Bard Peripheral Vascular Inc |
| Aug 20, 2026 | Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FH... | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... | Class II | Alere San Diego, Inc. |
| Aug 20, 2026 | REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series | Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was inclu... | Class II | DeRoyal Industries Inc |
| Aug 20, 2026 | CADD Yellow Medication Cassette Reservoir with NRFit connector US Product ... | Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue c... | Class II | ICU Medical, Inc. |
| Aug 20, 2026 | Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC... | Due to issue with endoscope adherence and inability to spray powder. Firm will provide an update... | Class II | Wilson-Cook Medical Inc. |
| Aug 19, 2026 | Presource Packs containing Medtronic Microstream Components: Intubation Ki... | Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of th... | Class II | Cardinal Health 200, LLC |
| Aug 19, 2026 | SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached ... | The proximal thread depth of the spinal device is out of design specification. | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Aug 19, 2026 | Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Numbe... | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adh... | Class II | Olympus Corporation of the Americas |
| Aug 19, 2026 | Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: ... | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adh... | Class II | Olympus Corporation of the Americas |
| Aug 19, 2026 | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model ... | Potential for the inflation chart label affixed to the shaft of the device to be incorrect and in... | Class II | Olympus Corporation of the Americas |
| Aug 19, 2026 | Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number:... | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adh... | Class II | Olympus Corporation of the Americas |
| Aug 19, 2026 | Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number... | Potential for detachment of ceramic tip due to manufacturing without the designated amount of adh... | Class II | Olympus Corporation of the Americas |
| Aug 19, 2026 | REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECH... | Reusable access port system may crack or seperate during use. | Class II | Stryker Sustainability Solutions |
| Aug 19, 2026 | REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLE... | Reusable access port system may crack or seperate during use. | Class II | Stryker Sustainability Solutions |
| Aug 19, 2026 | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alari... | Due to discrepancies in specific attributes in the performance data for infusion sets, which may ... | Class I | BD SWITZERLAND SARL |
| Aug 19, 2026 | REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLE... | Reusable access port system may crack or seperate during use. | Class II | Stryker Sustainability Solutions |
| Aug 19, 2026 | NOxBOXi Nitric Oxide Delivery System. | Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may le... | Class II | NOXBOX LTD |
| Aug 19, 2026 | REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEE... | Reusable access port system may crack or seperate during use. | Class II | Stryker Sustainability Solutions |
| Aug 19, 2026 | REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEE... | Reusable access port system may crack or seperate during use. | Class II | Stryker Sustainability Solutions |
| Aug 19, 2026 | REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECH... | Reusable access port system may crack or seperate during use. | Class II | Stryker Sustainability Solutions |
| Aug 18, 2026 | Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number:... | Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the d... | Class II | Cadwell Industries Inc |
| Aug 18, 2026 | The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained ... | In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to in... | Class II | Radiometer Medical ApS |
| Aug 18, 2026 | BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-... | Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight se... | Class II | Stryker Sustainability Solutions |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasit... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Pha... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
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.