Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 12, 2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M | The suture wings have the potential to crack or break. Potential patient injury includes catheter... | Class II | Medical Components, Inc dba MedComp |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 3, 2018 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip AR... | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter.... | Class II | Arrow International Inc |
| Jun 29, 2018 | 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product... | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2018 | 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling... | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Cat... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Cat... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 28, 2018 | Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with... | The torque wrench used on the ceiling column assembly during a recent service visit was outside o... | Class II | Bayer Medical Care, Inc. |
| Jun 22, 2018 | Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10... | Potential hardware issue which may cause thermal effects and possible damage to system parts. | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2018 | ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Produ... | Potential hardware issue which may cause thermal effects and possible damage to system parts. | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2018 | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators... | In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for th... | Class I | Philips Respironics, Inc. |
| Jun 4, 2018 | 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog N... | There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a ... | Class II | B. Braun Medical, Inc. |
| May 30, 2018 | ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 | During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotatio... | Class II | Siemens Medical Solutions USA, Inc |
| May 25, 2018 | Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Art... | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... | Class II | Siemens Medical Solutions USA, Inc |
| May 25, 2018 | AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is ... | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... | Class II | Siemens Medical Solutions USA, Inc |
| May 24, 2018 | Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalat... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inh... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhala... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 24, 2018 | Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usa... | The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC mo... | Class II | Draeger Medical, Inc. |
| May 23, 2018 | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr.... | Product contains dry natural rubber latex. Label states Latex Free. | Class II | Arrow International Inc |
| May 17, 2018 | VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Produc... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To prov... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 15, 2018 | Draeger Jaundice Meter JM-105 The device is intended for use in hospitals,... | Users have misinterpreted the display for out of range measurement indicated by the blinking "-... | Class I | Draeger Medical Systems, Inc. |
| May 15, 2018 | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals... | Users have misinterpreted the display for out of range measurement indicated by the blinking" ... | Class I | Draeger Medical Systems, Inc. |
| May 11, 2018 | Olympus JF-160F duodenoscopes (Model NumberJF-160F) | Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additiona... | Class II | Olympus Corporation of the Americas |
| May 11, 2018 | Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS... | The recalling firm has received complaints related to increased resistance encountered when intro... | Class II | Arrow International Inc |
| May 11, 2018 | Olympus JF-140F duodenoscopes (Model NumberJF-140F) | Issuance of validated, new reprocessing procedures. This corrective action is being undertaken ... | Class II | Olympus Corporation of the Americas |
| May 9, 2018 | Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Produ... | There is a potential for a different set to be mixed within the lot, where the incorrect set does... | Class II | B. Braun Medical, Inc. |
| May 4, 2018 | Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used... | The adapter may demonstrate a degradation of function as the final products were assembled with b... | Class II | Synthes (USA) Products LLC |
| May 1, 2018 | Artis zee floor MN, Material no. 10094142, for angiography and whole body rad... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q.zen biplane, Material no. 10848355, for angiography and whole body ra... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zee floor, Material no. 10094135, for angiography and whole body radiog... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zee ceiling, Material no. 10094137, for angiography and whole body radi... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zee biplane, Material no. 10094141, for angiography and whole body radi... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zee MP, Material no. 10094139, for angiography and whole body radiograp... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zeego, Material no. 10280959 , for angiography and whole body radiogra... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis zee biplane MN, Material no. 10094143, for angiography and whole body r... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000 | If the C-arm is manually moved in the longitudinal direction to a fully extended position, the sy... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q ceiling, Material no. 10848281, for angiography and whole body radiog... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q biplane, Material no. 10848282, for angiography and whole body radiog... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q.zeego, Material no. 10848283, for angiography and whole body radiogra... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| May 1, 2018 | Artis Q.zen floor, Material no. 10848353, for angiography and whole body radi... | After the Large Display returns from power save mode, it may not show an image, and stay black wi... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 26, 2018 | Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator f... | The valve assembly material may become corroded due to insufficient cleaning by a supplier. There... | Class II | Draeger Medical, Inc. |
| Apr 20, 2018 | SOMATOM go.Now, Material Number 11061618 There is a potential for a softw... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2018 | SOMATOM Go.Up, Material Number 11061628 There is a potential for a softwar... | There is a potential for a software issue that may cause the need for necessary patient rescans. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2018 | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+a... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International 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.