Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 11, 2018 | Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes:... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product C... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Maximal Barrier Drape; Product Code: ASK-01000-UPMS | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue Fl... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue F... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Produ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-2430... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Echogenic Needle; Product codes: PN-00215-E and PN-00217-E | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Multi-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.