Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV)… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV)… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat SPACE PUMP IV SET 15D, 90 IN Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV)… Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall REF: 60-7070-005, Zimmer, Tourniquet Cuff 30” (Blue), Luer-Lock Dual Port, single Bladder, RxOnly Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Illinois, Michigan, Oregon and Wisconsin named
- Medical device recall SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961 Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963 Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02,… Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component,… Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of… Class IIFDA’s classJul 24, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 24, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall BAUSCH+LOMB, I-PACK Injection Kit Sterilization certificates could not be validated by the supplier FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall BAUSCH+LOMB, I-PACK Injection Kit with Drape Sterilization certificates could not be validated by the supplier FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall BAUSCH+LOMB, I-PACK Injection Kit Custom Sterilization certificates could not be validated by the supplier FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum Sterilization certificates could not be validated by the supplier FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Pink Luminous Breast, Breast transilluminator Firm is marketing and distributing the Pink Luminous Breast device without premarket approval Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Rhode Island and Washington named
- Medical device recall 24K Premium Lense Contact lenses recalled due to potential bacterial contamination. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide, and California and Nevada named
- Medical device recall ALPHAMAXX Mobile Operating Table The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereKentucky, North Carolina, New York and Virginia
- Medical device recall ALPHAMAXX Mobile Operating Table The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereKentucky, North Carolina, New York and Virginia
- Medical device recall ALPHAMAXX Mobile Operating Table The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereKentucky, North Carolina, New York and Virginia
- Medical device recall AHAR50K STANDARD ARTHROSCOPY PACK - 291852 Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE - 302497- Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAJOR KNEE - 302497- Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LOWER EXTREMITY - 247542- Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE - 247546 - Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE - 247546 Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTHROSCOPY WOLFSON PACK BHS Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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