Medela AG
Mchenry, IL, US
MEDELA AG appears in FDA device records in Mchenry, IL. FDA records list 56 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Medela AG carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medela AG Medical Technologyenforcement report, recall
- Medela Inc. EF Divisionenforcement report, recall
- Medical Product Specialist Inc dba MPS Acaciarecall
510(k) clearance history
Showing 50 of 56FDA records hold 56 510(k) clearances for Medela AG between 1980 and 2026. The busiest year on record is 2015, with 5. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 2 |
| 1988 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 1999 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 5 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253510 | Freestyle Mini Hands-free | HGX | Substantially Equivalent | |
| K253149 | Motion InBra (YM-8801) wearable breast pump | HGX | Substantially Equivalent | |
| K253498 | Pump In Style® Pro+ | HGX | Substantially Equivalent | |
| K251377 | Magic InBra | HGX | Substantially Equivalent | |
| K232608 | Duo Hands-free Breast Pump | HGX | Substantially Equivalent | |
| K223388 | Invia® Integrated Dressing | OMP | Substantially Equivalent | |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | OMP | Substantially Equivalent | |
| K210759 | Solo, Swing Maxi | HGX | Substantially Equivalent | |
| K200508 | Pump In Style | HGX | Substantially Equivalent | |
| K191653 | Freestyle Flex | HGX | Substantially Equivalent | |
| K182191 | Invia Abdominal Dressing Kit | OMP | Substantially Equivalent | |
| K180415 | Invia White Foam NPWT | OMP | Substantially Equivalent | |
| K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | HGX | Substantially Equivalent | |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | OMP | Substantially Equivalent | |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film | OMP | Substantially Equivalent | |
| K161811 | Medela Low Dose Enteral Syringe | PNR | Substantially Equivalent | |
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply | OMP | Substantially Equivalent | |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | HGX | Substantially Equivalent | |
| K153663 | Vario 8/18/ci | BTA | Substantially Equivalent | |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental | HGX | Substantially Equivalent | |
| K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large | OMP | Substantially Equivalent | |
| K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters | OMP | Substantially Equivalent | |
| K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty | HGX | Substantially Equivalent | |
| K150134 | Basic, Dominant Flex, KV-6 | QPB | Substantially Equivalent | |
| K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM | OMP | Substantially Equivalent | |
| K141553 | MEDELA THOPAZ+ | BTA | Substantially Equivalent | |
| K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | BTA | Substantially Equivalent | |
| K130210 | MEDELA THOPAZ | BTA | Substantially Equivalent | |
| K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM | OMP | Substantially Equivalent | |
| K080357 | MEDELA INVIA WOUND THERAPY | OMP | Substantially Equivalent | |
| K080212 | MEDELA THOPAZ, MODEL 200 0288 | BTA | Substantially Equivalent | |
| K063336 | MEDELA DOMINANT 50 LIPO, MODEL 600-5706 | QPB | Substantially Equivalent | |
| K061205 | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR | BTA | Substantially Equivalent | |
| K061435 | MEDELA VARIO SUCTION PUMPS | OMP | Substantially Equivalent | |
| K053052 | MEDELA SWING BREAST PUMP | HGX | Substantially Equivalent | |
| K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | HDB | Substantially Equivalent | |
| K043544 | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR | BTA | Substantially Equivalent | |
| K033179 | MEDELA CLARIO HOME CARE PUMP | BTA | Substantially Equivalent | |
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | HGX | Substantially Equivalent | |
| K021368 | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 | BTA | Substantially Equivalent | |
| K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | HGX | Substantially Equivalent | |
| K984589 | PHOTOTHERAPY LAMP | LBI | Substantially Equivalent | |
| K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO | BTA | Substantially Equivalent | |
| K962612 | BILIBED PHOTOTHERAPY LAMP | LBI | Substantially Equivalent | |
| K950750 | MEDELAS BREAST PUMP | HGX | Substantially Equivalent | |
| K952034 | MEDELA'S FOOT PUMP | HGY | Substantially Equivalent | |
| K923577 | BREAST SHELLS | HFS | Substantially Equivalent | |
| K901344 | MEDELA BATTERY OPERATED BREAST PUMP | HGX | Substantially Equivalent | |
| K875300 | MEDELA BREAST-PUMP LACTINA | HGX | Substantially Equivalent | |
| K853176 | CANNON BABYSAFE NIPPLE SHIELDS | HFS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002807523 | 3002807523 | MEDELA AG | LAETTICHSTRASSE 4B, BAAR Zug CH-6340 CH | 2026 | and 4 more, listed in full below |
| 1419937 | 1419937 | MEDELA LLC | 1101 CORPORATE DR., MCHENRY, IL 60050 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IQGAdaptor, Holder, Syringe
- KDQBottle, Collection, Vacuum
- PWABreast Pump Accessory, Milk Expression Aid, Via Positive Pressure
- OHHBreast Pump Kit
- PNREnteral Syringes With Enteral Specific Connectors
- HDBExtractor, Vacuum, Fetal
- FQHLavage, Jet
- FTLMesh, Surgical, Polymeric
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- FNNNipple, Lambs Feeding
- NTCNursing Pad, Hydrogel
- IMEPack, Hot Or Cold, Reusable
- HGYPump, Breast, Non-Powered
- HGXPump, Breast, Powered
- BTAPump, Portable, Aspiration (Manual Or Powered)
- FRWScale, Patient
- FPASet, Administration, Intravascular
- HFSShield, Nipple
- FMFSyringe, Piston
- QPBSystem, Suction, Lipoplasty For Removal
- LHBTimer, Apgar
- KNTTubes, Gastrointestinal (And Accessories)
- LBIUnit, Neonatal Phototherapy
- ILCUtensil, Eating
- LGZWarmer, Thermal, Infusion Fluid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2645-2026 | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit Component: N/A | May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication. | Class II | Open, Classified | |
| Z-1502-2021 | Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump. | Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24". | Class II | Terminated | |
| Z-0773-2020 | Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size). | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. | Class II | Terminated | |
| Z-2061-2019 | Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 | The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. | Class III | Terminated | |
| Z-2528-2018 | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. | Device may display a battery missing error. | Class II | Terminated | |
| Z-1262-2015 | - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile. | The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging. | Class II | Terminated | |
| Z-3172-2011 | Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118 | Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain". | Terminated | ||
| Z-2553-2011 | Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby. | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | Terminated | ||
| Z-2386-2011 | AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps. | The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled. | Terminated | ||
| Z-1224-2011 | Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged; h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk. | The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise. | Terminated | ||
| Z-2486-2010 | Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | Terminated | ||
| Z-2485-2010 | Sterile single/double breast personal accessory convenience kit for single or double pumping with a Classic Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article #67093S | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | Terminated | ||
| Z-2484-2010 | Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breast pumps; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article #67116S | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | Terminated | ||
| Z-2483-2010 | Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article # 67099S | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | Terminated | ||
| Z-1442-2010 | Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b) Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099, Symphony Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits; e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts; | The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use. | Terminated | ||
| Z-1080-2010 | Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte | Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism. | Terminated | ||
| Z-1079-2010 | Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte | Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism. | Terminated | ||
| Z-1078-2010 | Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte | Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism. | Terminated | ||
| Z-1077-2010 | Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte | Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism. | Terminated | ||
| Z-1076-2010 | Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte | Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Medela AG edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain