Browse Device Recalls
71 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 71 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 71 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 20, 2022 | Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Oct 20, 2022 | Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S... | Class I | Remel Inc |
| Jan 10, 2022 | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD ... | There are lower than expected MICs for some gram negative species. | Class II | Remel Inc |
| Jun 18, 2021 | ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the... | Out of Specification | Class II | Remel Inc |
| Apr 22, 2021 | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/pack... | The media allows growth of E. faecalis ATCC 29212 with blackening of the media. | Class II | Remel Inc |
| Mar 10, 2021 | Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus ... | When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than n... | Class II | Remel Inc |
| Mar 10, 2021 | Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus... | When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than n... | Class II | Remel Inc |
| Dec 10, 2020 | Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 | The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for us... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for us... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use i... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use ... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for u... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for us... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for u... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use ... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use i... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use i... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Apr 17, 2019 | Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for ... | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at... | Class II | Remel Inc |
| Jan 4, 2019 | SWIN 2017 database, Model YSW4000 | Potential for out of range microbial results | Class II | Remel Inc. |
| Aug 13, 2018 | remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, ... | Products have intermittently failed performance testing during stability studies with various ana... | Class II | Remel Inc |
| Aug 13, 2018 | remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 ... | Products have intermittently failed performance testing during stability studies with various ana... | Class II | Remel Inc |
| Aug 13, 2018 | remel THIOGLYCOLLATE MEDIUM, REF 05152 | Products have intermittently failed performance testing during stability studies with various ana... | Class II | Remel Inc |
| Dec 8, 2017 | Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. ... | The serum may fail to agglutinate within the specified minimum reaction time. | Class II | Remel Inc |
| Nov 2, 2017 | CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. | Product may have incorrect cation information detailed on the product label. | Class II | Remel Inc |
| Mar 24, 2017 | Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel,... | Confirmed complaint of surface contamination of Listeria monocytogenes. | Class II | Remel Inc |
| Feb 9, 2017 | Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm ... | Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users... | Class II | Remel Inc |
| Mar 24, 2016 | Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For... | Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delay... | Class II | Remel Inc |
| Nov 6, 2015 | Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT002... | Antibiotic concentration may be insufficient which may result in incorrect test results. | Class II | Remel Inc |
| Jun 30, 2015 | PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper b... | A reagent present may produce weak or slow reactions; continued use may result in a failure to id... | Class II | Remel Inc |
| Jun 30, 2015 | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex ... | A reagent present may produce weak or slow reactions; continued use may result in a failure to id... | Class II | Remel Inc |
| May 19, 2015 | VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The ... | Use of the recalled product may result in false positive reports. | Class II | Remel Inc |
| May 19, 2015 | VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The ... | Use of the recalled product may result in false positive reports. | Class II | Remel Inc |
| May 4, 2015 | Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per ... | Product may be contaminated with Listeria monocytogenes. | Class II | Remel Inc |
| Feb 5, 2015 | Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ... | Use of the product may not provide adequate recovery and could result in false negative identific... | Class II | Remel Inc |
| Nov 13, 2014 | Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. ... | Use of the product could result in inadequate recovery of Legionella pneumophila which could resu... | Class II | Remel Inc |
| Oct 29, 2014 | Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottl... | The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosi... | Class II | Remel Inc |
| Oct 23, 2014 | Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests ... | A reagent within the test may return false negative results. | Class II | Remel Inc |
| Oct 23, 2014 | Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box co... | A reagent within the test may return false negative results. | Class II | Remel Inc |
| Oct 17, 2014 | Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10... | Recalled product may not provide adequate recovery of Legionella pneumophila when used as directe... | Class II | Remel 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.