Windstone Medical Packaging, Inc. recalls
Every recall we track for Windstone Medical Packaging, Inc. — 40 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 5 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Windstone Medical Packaging, Inc. dropped to zero in 2025 (0, down from 5 in 2024). 13% rated “stop using now”.
All FDA recall records for Windstone Medical Packaging, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 0 | 0 | 0 | 1 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 2 | 1 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 2 | 2 |
| 2023 | 0 | 3 | 4 | 0 | 7 |
| 2024 | 0 | 0 | 0 | 5 | 5 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 4 | 1 | 10 | 7 | 22 |
Most common reasons for Windstone Medical Packaging, Inc. recalls
What to do if you have a recalled Windstone Medical Packaging, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Windstone Medical Packaging, Inc. recalls
15 shown- Stop using nowMedical device
Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Windstone Medical recalls AMS Convenience Kit (DSAek Pack) with possible blue break-off parts that may detach during use. Affected units include specific lot numbers from 2022-2023. Stop using immediately to avoid potential injury.
Windstone MedicalJul 29, 2026 - UnratedMedical device
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part
Windstone Medical Packaging recalls specific AMS medical convenience kits containing Elevaris Lidocaine HCl injection USP due to supplier quality issues. Affected kits include Dr Fred Chiu Single Shot Epi Trays with listed part numbers and lot numbers.
Windstone Medical PackagingJun 17, 2026 - UnratedMedical device
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2)
Windstone Medical Packaging recalls specific spine surgery kits for potential endotoxin level variations that could affect medical procedures.
Windstone Medical PackagingJun 8, 2026 - Lower riskMedical device
Windstone Medical Packaging, Inc. recalls A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Windstone Medical Packaging recalls surgical convenience kits with contaminated alcohol prep pads. The kits contain a contaminant (Paenibacillus phoenicis) found during sterilization audits. Affected kits have specific lot numbers.
Windstone Medical PackagingMay 21, 2026 - UnratedMedical device
Windstone Medical Packaging, Inc. recalls Aligned Medical AMS16835 Fluids Kit RX
Windstone Medical recalls AMS16835 Fluids Kit due to quality issues with lidocaine injection. Affected lot numbers include 233828, 236048, 236359, 236662, 238580, 239934, 239935.
Windstone MedicalApr 27, 2026 - Use cautionMedical device
Windstone Medical Packaging, Inc. recalls Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA
Windstone Medical recalls Custom Convenience Kits with Medline Namic RA Syringes due to risk of adapter unwinding causing potential biohazard exposure, blood loss, or infection. Affected kits include specific part numbers and lots.
Windstone MedicalApr 2, 2026 - Stop using nowMedical device
Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Windstone Medical Packaging recalls Custom Convenience Kits Pre Op Kit (AMS14994) due to potential backflow of medication between IV containers, risking contamination. Affected units include specific lot numbers.
Windstone Medical PackagingMar 11, 2026 - UnratedMedical device
Windstone Medical Packaging, Inc. recalls Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a
Windstone Medical Packaging recalls Aligned Medical Septo Pack REF AMS11480 with Cardinal Health Salem Sump PVC tubes due to improper use risks. Affected units include specific lot numbers.
Windstone Medical PackagingAug 16, 2024 - Lower riskMedical device
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Windstone Medical recalls sterile ocular packs AMS12947 STERILEEO due to potential sterility issues in surgical kits. Affected lots 192389 and 194805 may not be sterile, risking infection during procedures.
Windstone MedicalDec 22, 2023 - Use cautionMedical device
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Windstone Medical recalls Aligned Hand Pack REF AmS460: P2 Cover Light Handle Blue STE may detach during use, risking procedure delays or patient injury. Affected units contain Lot 188843.
Windstone MedicalApr 24, 2023 - UnratedMedical device
Windstone Medical Packaging, Inc. recalls Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit
Windstone Medical Packaging recalls custom surgical instrument disposable kits containing 3M Steri-Drape surgical drapes that were previously recalled by 3M Healthcare. Affected kits include various surgical packs with specific part numbers and lot numbers.
Windstone Medical PackagingNov 1, 2022 - UnratedMedical device
Windstone Medical Packaging, Inc. recalls Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with
Aligned Medical Solutions convenience kits containing Prevantics swabs or swabsticks are recalled due to uncertainty in drug manufacturing validation. Affected kits have specific AMS pack numbers and production dates.
Windstone Medical PackagingMar 21, 2022 - Use cautionMedical device
Windstone Medical Packaging, Inc. recalls Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical
Windstone Medical Packaging recalls Monoject 0.9% Sodium Chloride 10mL syringes in specific kits from July 2019-July 2021 due to potential air reintroduction after expelling air. Affected kits include AMS-9041CP, AMS-9046CP-1, and others with listed lot numbers.
Windstone Medical PackagingAug 19, 2021 - Use cautionMedical device
Windstone Medical Packaging, Inc. recalls Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover
Windstone Medical Packaging recalls 114 Angio Pack kits (REF AMS6908C) due to insufficient angio tubing welds. Check lot numbers 146304 and 147534.
Windstone Medical PackagingApr 8, 2021 - Stop using nowMedical device
Windstone Medical Packaging, Inc. recalls AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Windstone Medical recalls sterile surgical kits AMS6357 with potential sterile barrier breach. Affected kits include Lot #109138. Stop using immediately to avoid infection risks.
Windstone MedicalOct 24, 2017
Windstone Medical Packaging, Inc. recall questions
How many recalls has Windstone Medical Packaging, Inc. had?
40 recalls from Windstone Medical Packaging, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Windstone Medical Packaging, Inc. recall?
Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B, dated Jul 29, 2026. Every Windstone Medical Packaging, Inc. recall is listed on this page, newest first.
Why are Windstone Medical Packaging, Inc. products recalled?
The most common reasons on record: Sterility assurance for saline included in surgical kits cannot be guaranteed. (4).
What should I do if I have a recalled Windstone Medical Packaging, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Windstone Medical Packaging, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.